Trial Outcomes & Findings for Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors (NCT NCT02001623)
NCT ID: NCT02001623
Last Updated: 2021-12-29
Results Overview
Evaluation of treatment-emergent adverse events (TEAEs) includes number of participants with at least one: TEAE Serious TEAE Infusion-related TEAE Common Terminology Criteria for Adverse Events (CTCAE) grade \>=3 Treatment-related TEAE A CTCAE TEAE was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
195 participants
Primary outcome timeframe
Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the dose escalation part.
Results posted on
2021-12-29
Participant Flow
In the dose escalation part of the study, 40 participants were screened and 27 were enrolled and received treatment. In the dose expansion part of the study, 294 participants were screened and 168 were enrolled and received treatment.
Participant milestones
| Measure |
Dose Escalation Part: 0.3 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Escalation Part: 1.5 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Bladder Cancer
Participants with bladder cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Completed 4 Cycles of Treatment
|
0
|
1
|
1
|
2
|
0
|
2
|
2
|
1
|
5
|
31
|
6
|
4
|
6
|
22
|
7
|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
6
|
15
|
55
|
14
|
15
|
15
|
36
|
18
|
|
Overall Study
Completed 12 Cycles of Treatment
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
2
|
3
|
3
|
3
|
6
|
15
|
53
|
14
|
15
|
14
|
35
|
18
|
Reasons for withdrawal
| Measure |
Dose Escalation Part: 0.3 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Escalation Part: 1.5 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Bladder Cancer
Participants with bladder cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Disease Progression
|
2
|
2
|
3
|
2
|
3
|
2
|
3
|
3
|
7
|
40
|
5
|
9
|
9
|
20
|
9
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
2
|
3
|
3
|
1
|
2
|
1
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
3
|
4
|
6
|
4
|
0
|
3
|
5
|
6
|
|
Overall Study
Other - Miscellaneous
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
2
|
2
|
1
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Start of New Anti-cancer Treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Dose Delay Due to Toxicity
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors
Baseline characteristics by cohort
| Measure |
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Bladder Cancer
n=15 Participants
Participants with bladder cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
n=55 Participants
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
n=14 Participants
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
n=15 Participants
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
n=15 Participants
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
n=36 Participants
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
n=18 Participants
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
In utero
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Age, Customized
Preterm newborn infants (gestational age < 37 wks)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Age, Customized
Children (2-11 years)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Age, Customized
Adults (18-64 years)
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
51 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
9 Participants
n=36 Participants
|
26 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
138 Participants
n=135 Participants
|
|
Age, Customized
From 65-84 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
10 Participants
n=36 Participants
|
14 Participants
n=24 Participants
|
57 Participants
n=135 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
55 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
36 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
140 Participants
n=135 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
18 Participants
n=24 Participants
|
55 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
53 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
15 Participants
n=36 Participants
|
35 Participants
n=36 Participants
|
18 Participants
n=24 Participants
|
191 Participants
n=135 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
49 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
13 Participants
n=36 Participants
|
34 Participants
n=36 Participants
|
17 Participants
n=24 Participants
|
182 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Black or Asian American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
PRIMARY outcome
Timeframe: Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the dose escalation part.Evaluation of treatment-emergent adverse events (TEAEs) includes number of participants with at least one: TEAE Serious TEAE Infusion-related TEAE Common Terminology Criteria for Adverse Events (CTCAE) grade \>=3 Treatment-related TEAE A CTCAE TEAE was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Part: Evaluation of Treatment-Emergent Adverse Events
TEAEs
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
—
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Evaluation of Treatment-Emergent Adverse Events
Serious TEAEs
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
—
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Evaluation of Treatment-Emergent Adverse Events
Infusion-Related TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Evaluation of Treatment-Emergent Adverse Events
CTCAE Grade >=3 TEAEs
|
2 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
—
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Evaluation of Treatment-Emergent Adverse Events
TEAEs Related to Study Drug
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
—
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 325 days in the dose expansion part.Evaluation of treatment-emergent adverse events (TEAEs) includes number of participants with at least one: TEAE Serious TEAE Infusion-related TEAE Common Terminology Criteria for Adverse Events (CTCAE) grade \>=3 Treatment-related TEAE A CTCAE TEAE was determined using the CTCAE grading systems based on NCI-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=15 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=36 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=18 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=15 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=55 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=14 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=15 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Part: Evaluation of Treatment-Emergent Adverse Events
CTCAE Grade >=3 TEAEs
|
10 Participants
|
16 Participants
|
11 Participants
|
—
|
—
|
9 Participants
|
30 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part: Evaluation of Treatment-Emergent Adverse Events
TEAEs
|
15 Participants
|
36 Participants
|
18 Participants
|
—
|
—
|
15 Participants
|
55 Participants
|
14 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part: Evaluation of Treatment-Emergent Adverse Events
Serious TEAEs
|
6 Participants
|
13 Participants
|
6 Participants
|
—
|
—
|
7 Participants
|
26 Participants
|
5 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part: Evaluation of Treatment-Emergent Adverse Events
Infusion-Related TEAEs
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Part: Evaluation of Treatment-Emergent Adverse Events
TEAEs Related to Study Drug
|
14 Participants
|
36 Participants
|
18 Participants
|
—
|
—
|
15 Participants
|
54 Participants
|
13 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to end of follow-up, up to a maximum of 60 weeksNumber of participants with markedly abnormal hematology values was defined as all participants who experienced at least 1 CTCAE grade \>= 3 hematology value. A markedly abnormal hematology value was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
n=15 Participants
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
n=55 Participants
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
n=14 Participants
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
n=15 Participants
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
n=15 Participants
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
n=36 Participants
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
n=18 Participants
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Part: Number of Participants With Markedly Abnormal Hematology Values
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
23 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 to end of follow-up, up to a maximum of 60 weeksNumber of participants with markedly abnormal coagulation values was defined as all participants who experienced at least 1 CTCAE grade \>= 3 coagulation value. A markedly abnormal coagulation value was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
n=15 Participants
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
n=55 Participants
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
n=14 Participants
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
n=15 Participants
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
n=15 Participants
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
n=36 Participants
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
n=18 Participants
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Parts: Number of Participants With Markedly Abnormal Coagulation Values
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1 to end of follow-up, up to a maximum of 60 weeksNumber of participants with markedly abnormal biochemistry results were defined as all participants who experienced at least 1 CTCAE grade \>= 3 biochemistry value. A markedly abnormal biochemistry value was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
n=15 Participants
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
n=55 Participants
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
n=14 Participants
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
n=15 Participants
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
n=15 Participants
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
n=36 Participants
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
n=18 Participants
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Part: Number of Participants With Markedly Abnormal Biochemistry Values
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
8 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
9 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1 to end of follow-up, up to a maximum of 60 weeksOutcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
n=15 Participants
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
n=55 Participants
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
n=14 Participants
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
n=15 Participants
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
n=15 Participants
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
n=36 Participants
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
n=18 Participants
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Parts: Number of Participants Who Experienced a Skin Rash
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 1 to end of follow-up, up to a maximum of 60 weeksBleeding adverse events of special interest included treatment emergent adverse events with preferred terms within the following standardised MedDRA queries (SMQs): Haemorrhage terms, excluding laboratory terms SMQ \[20000039\] (Broad) and Haemorrhage, laboratory terms SMQ \[20000040\] (Narrow). Bleeding adverse events of special interest were evaluated according to the NCI-CTCAE version 4.03. Bleeding events of all grades are included. Grade 1:Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
n=15 Participants
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
n=55 Participants
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
n=14 Participants
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
n=15 Participants
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
n=15 Participants
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
n=36 Participants
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
n=18 Participants
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Parts: Number of Participants Who Experienced a Bleeding Event of Special Interest
|
3 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
10 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
31 Participants
|
10 Participants
|
7 Participants
|
9 Participants
|
27 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Day 1 to end of follow-up, up to a maximum of 60 weeksPeripheral neuropathy events of special interest were evaluated according to the NCI-CTCAE version 4.03. Peripheral neuropathy events of all grades are included in the numbers below. Grade 1:Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
n=15 Participants
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
n=55 Participants
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
n=14 Participants
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
n=15 Participants
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
n=15 Participants
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
n=36 Participants
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
n=18 Participants
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Part: Number of Participants Who Experienced a Peripheral Neuropathy Event
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
17 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
17 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)Population: PK analysis set: all participants who had been exposed to tisotumab vedotin and had at least 1 PK assessment after first dose.
Pharmacokinetic (PK) parameters in plasma were determined based on non compartmental methods and calculated separately for Cycle 1 and Cycle 2 in each part of the study. Data was not collected to report or calculate clearance for the expansion phase.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=5 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Part: Clearance of Tisotumab Vedotin and Total HuMax-TF
Tisotumab Vedotin: Cycle 1
|
1.84 mL/hr/kg
Geometric Coefficient of Variation 20.59
|
1.17 mL/hr/kg
Geometric Coefficient of Variation 60.05
|
1.56 mL/hr/kg
Geometric Coefficient of Variation 34.12
|
0.87 mL/hr/kg
Geometric Coefficient of Variation 8.93
|
—
|
—
|
1.61 mL/hr/kg
Geometric Coefficient of Variation 7.79
|
1.46 mL/hr/kg
Geometric Coefficient of Variation 15.23
|
1.07 mL/hr/kg
Geometric Coefficient of Variation 11.60
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Clearance of Tisotumab Vedotin and Total HuMax-TF
Tisotumab Vedotin: Cycle 2
|
2.05 mL/hr/kg
Geometric Coefficient of Variation 26.80
|
0.93 mL/hr/kg
Geometric Coefficient of Variation 24.03
|
1.30 mL/hr/kg
Geometric Coefficient of Variation 19.06
|
1.03 mL/hr/kg
Geometric Coefficient of Variation 11.34
|
—
|
—
|
1.72 mL/hr/kg
Geometric Coefficient of Variation 4.98
|
1.44 mL/hr/kg
Geometric Coefficient of Variation 6.32
|
1.07 mL/hr/kg
Geometric Coefficient of Variation 10.45
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Clearance of Tisotumab Vedotin and Total HuMax-TF
Total HuMax-TF: Cycle 1
|
1.26 mL/hr/kg
Geometric Coefficient of Variation 31.29
|
0.81 mL/hr/kg
Geometric Coefficient of Variation 69.72
|
0.87 mL/hr/kg
Geometric Coefficient of Variation 33.85
|
0.56 mL/hr/kg
Geometric Coefficient of Variation 14.13
|
—
|
—
|
1.02 mL/hr/kg
Geometric Coefficient of Variation 0.20
|
0.98 mL/hr/kg
Geometric Coefficient of Variation 16.90
|
0.69 mL/hr/kg
Geometric Coefficient of Variation 12.61
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Clearance of Tisotumab Vedotin and Total HuMax-TF
Total HuMax-TF: Cycle 2
|
1.40 mL/hr/kg
Geometric Coefficient of Variation 31.39
|
0.53 mL/hr/kg
Geometric Coefficient of Variation 12.41
|
0.82 mL/hr/kg
Geometric Coefficient of Variation 26.45
|
0.61 mL/hr/kg
Geometric Coefficient of Variation 9.72
|
—
|
—
|
1.05 mL/hr/kg
Geometric Coefficient of Variation 9.95
|
0.98 mL/hr/kg
Geometric Coefficient of Variation 6.52
|
0.71 mL/hr/kg
Geometric Coefficient of Variation 13.41
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)Population: PK analysis set: all participants who had been exposed to tisotumab vedotin and had at least 1 PK assessment after first dose.
PK parameters in plasma were determined based on non compartmental methods and calculated separately for Cycle 1 and Cycle 2 in each part of the study. Data was not planned to be collected for the volume of distribution of tisotumab vedotin and total HuMax-TF for the dose expansion part.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=5 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Part: Volume of Distribution of Tisotumab Vedotin and Total HuMax-TF
Total HuMax-TF: Cycle 2
|
84.98 mL/kg
Geometric Coefficient of Variation 22.85
|
50.62 mL/kg
Geometric Coefficient of Variation 36.02
|
60.40 mL/kg
Geometric Coefficient of Variation 17.48
|
58.10 mL/kg
Geometric Coefficient of Variation 12.31
|
—
|
—
|
55.75 mL/kg
Geometric Coefficient of Variation 10.80
|
57.13 mL/kg
Geometric Coefficient of Variation 8.90
|
58.48 mL/kg
Geometric Coefficient of Variation 12.66
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Volume of Distribution of Tisotumab Vedotin and Total HuMax-TF
Tisotumab Vedotin: Cycle 1
|
86.10 mL/kg
Geometric Coefficient of Variation 12.38
|
81.13 mL/kg
Geometric Coefficient of Variation 35.60
|
92.04 mL/kg
Geometric Coefficient of Variation 21.62
|
61.46 mL/kg
Geometric Coefficient of Variation 18.07
|
—
|
—
|
68.40 mL/kg
Geometric Coefficient of Variation 11.84
|
70.80 mL/kg
Geometric Coefficient of Variation 14.54
|
63.46 mL/kg
Geometric Coefficient of Variation 16.87
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Volume of Distribution of Tisotumab Vedotin and Total HuMax-TF
Tisotumab Vedotin: Cycle 2
|
99.20 mL/kg
Geometric Coefficient of Variation 20.82
|
70.21 mL/kg
Geometric Coefficient of Variation 42.93
|
74.82 mL/kg
Geometric Coefficient of Variation 4.19
|
72.74 mL/kg
Geometric Coefficient of Variation 5.79
|
—
|
—
|
76.69 mL/kg
Geometric Coefficient of Variation 9.53
|
69.74 mL/kg
Geometric Coefficient of Variation 7.99
|
62.61 mL/kg
Geometric Coefficient of Variation 6.03
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Volume of Distribution of Tisotumab Vedotin and Total HuMax-TF
Total HuMax-TF: Cycle 1
|
77.55 mL/kg
Geometric Coefficient of Variation 10.74
|
67.26 mL/kg
Geometric Coefficient of Variation 50.61
|
68.69 mL/kg
Geometric Coefficient of Variation 30.52
|
50.69 mL/kg
Geometric Coefficient of Variation 7.20
|
—
|
—
|
51.55 mL/kg
Geometric Coefficient of Variation 1.61
|
60.27 mL/kg
Geometric Coefficient of Variation 17.79
|
57.38 mL/kg
Geometric Coefficient of Variation 8.65
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)Population: PK analysis set: all participants who had been exposed to tisotumab vedotin and had at least 1 PK assessment after first dose.
PK parameters in plasma were determined based on non-compartmental methods and calculated separately for Cycle 1 and Cycle 2 in each part of the study.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
n=168 Participants
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Part: Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Tisotumab Vedotin and Total HuMax-TF
Tisotumab Vedotin: Cycle 1
|
33.1 day*ug/mL
Geometric Coefficient of Variation 19.0
|
63.0 day*ug/mL
Geometric Coefficient of Variation 49.3
|
52.3 day*ug/mL
Geometric Coefficient of Variation 33.1
|
84.9 day*ug/mL
Geometric Coefficient of Variation 33.7
|
79.31 day*ug/mL
Geometric Coefficient of Variation 49.40
|
2.5 day*ug/mL
Geometric Coefficient of Variation 3.1
|
15.4 day*ug/mL
Geometric Coefficient of Variation 8.2
|
25.1 day*ug/mL
Geometric Coefficient of Variation 16.9
|
45.2 day*ug/mL
Geometric Coefficient of Variation 9.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Part: Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Tisotumab Vedotin and Total HuMax-TF
Tisotumab Vedotin: Cycle 2
|
29.8 day*ug/mL
Geometric Coefficient of Variation 25.1
|
42.7 day*ug/mL
Geometric Coefficient of Variation 72.7
|
62.7 day*ug/mL
Geometric Coefficient of Variation 21.5
|
86.3 day*ug/mL
Geometric Coefficient of Variation 14.4
|
68.54 day*ug/mL
Geometric Coefficient of Variation 55.49
|
2.0 day*ug/mL
Geometric Coefficient of Variation 15.7
|
9.9 day*ug/mL
Geometric Coefficient of Variation 49.1
|
25.6 day*ug/mL
Geometric Coefficient of Variation 7.1
|
45.2 day*ug/mL
Geometric Coefficient of Variation 10.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Part: Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Tisotumab Vedotin and Total HuMax-TF
Total HuMax-TF: Cycle 1
|
44.9 day*ug/mL
Geometric Coefficient of Variation 27.8
|
86.7 day*ug/mL
Geometric Coefficient of Variation 54.3
|
85.9 day*ug/mL
Geometric Coefficient of Variation 36.7
|
123.0 day*ug/mL
Geometric Coefficient of Variation 34.7
|
112.70 day*ug/mL
Geometric Coefficient of Variation 45.23
|
2.9 day*ug/mL
Geometric Coefficient of Variation 0.5
|
15.4 day*ug/mL
Geometric Coefficient of Variation 53.1
|
35.0 day*ug/mL
Geometric Coefficient of Variation 18.9
|
60.4 day*ug/mL
Geometric Coefficient of Variation 13.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Part: Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Tisotumab Vedotin and Total HuMax-TF
Total HuMax-TF: Cycle 2
|
40.9 day*ug/mL
Geometric Coefficient of Variation 26.2
|
60.2 day*ug/mL
Geometric Coefficient of Variation 76.6
|
92.5 day*ug/mL
Geometric Coefficient of Variation 33.4
|
133.6 day*ug/mL
Geometric Coefficient of Variation 13.9
|
114.54 day*ug/mL
Geometric Coefficient of Variation 45.83
|
2.4 day*ug/mL
Geometric Coefficient of Variation 12.3
|
14.4 day*ug/mL
Geometric Coefficient of Variation 55.4
|
35.7 day*ug/mL
Geometric Coefficient of Variation 7.1
|
58.8 day*ug/mL
Geometric Coefficient of Variation 15.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)Population: PK analysis set: all participants who had been exposed to tisotumab vedotin and had at least 1 PK assessment after first dose.
PK parameters in plasma were determined based on non compartmental methods and calculated separately for Cycle 1 and Cycle 2. AUC0-inf was only analyzed in the dose escalation part of the study. Data was not planned to be collected for the AUC0-inf of tisotumab vedotin and total HuMax-TF for the dose expansion part.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Part: Area Under the Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tisotumab Vedotin and Total HuMax-TF
Tisotumab Vedotin: Cycle 1
|
33.95 day*ug/mL
Geometric Coefficient of Variation 20.93
|
63.88 day*ug/mL
Geometric Coefficient of Variation 48.61
|
53.47 day*ug/mL
Geometric Coefficient of Variation 30.88
|
105.84 day*ug/mL
Geometric Coefficient of Variation 8.68
|
—
|
—
|
15.57 day*ug/mL
Geometric Coefficient of Variation 7.81
|
25.77 day*ug/mL
Geometric Coefficient of Variation 15.70
|
46.68 day*ug/mL
Geometric Coefficient of Variation 10.99
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Area Under the Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tisotumab Vedotin and Total HuMax-TF
Tisotumab Vedotin: Cycle 2
|
30.56 day*ug/mL
Geometric Coefficient of Variation 26.43
|
80.59 day*ug/mL
Geometric Coefficient of Variation 24.03
|
64.10 day*ug/mL
Geometric Coefficient of Variation 19.06
|
88.95 day*ug/mL
Geometric Coefficient of Variation 11.04
|
—
|
—
|
14.52 day*ug/mL
Geometric Coefficient of Variation 4.98
|
26.12 day*ug/mL
Geometric Coefficient of Variation 6.44
|
46.59 day*ug/mL
Geometric Coefficient of Variation 9.98
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Area Under the Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tisotumab Vedotin and Total HuMax-TF
Total HuMax-TF: Cycle 1
|
48.19 day*ug/mL
Geometric Coefficient of Variation 35.67
|
90.08 day*ug/mL
Geometric Coefficient of Variation 52.74
|
93.29 day*ug/mL
Geometric Coefficient of Variation 30.45
|
157.81 day*ug/mL
Geometric Coefficient of Variation 12.70
|
—
|
—
|
23.75 day*ug/mL
Geometric Coefficient of Variation 0.20
|
37.02 day*ug/mL
Geometric Coefficient of Variation 16.39
|
69.96 day*ug/mL
Geometric Coefficient of Variation 13.26
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Area Under the Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tisotumab Vedotin and Total HuMax-TF
Total HuMax-TF: Cycle 2
|
43.41 day*ug/mL
Geometric Coefficient of Variation 30.31
|
136.08 day*ug/mL
Geometric Coefficient of Variation 12.41
|
98.59 day*ug/mL
Geometric Coefficient of Variation 26.45
|
145.82 day*ug/mL
Geometric Coefficient of Variation 9.42
|
—
|
—
|
23.01 day*ug/mL
Geometric Coefficient of Variation 9.95
|
37.08 day*ug/mL
Geometric Coefficient of Variation 6.37
|
67.93 day*ug/mL
Geometric Coefficient of Variation 14.25
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)Population: PK analysis set: all participants who had been exposed to tisotumab vedotin and had at least 1 PK assessment after first dose.
PK parameters in plasma were determined based on non-compartmental methods and calculated separately for Cycle 1 and Cycle 2 in each part of the study.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
n=168 Participants
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Part: Maximum Observed Plasma Concentration (Cmax) of Tisotumab Vedotin and Total HuMax-TF
Tisotumab Vedotin: Cycle 1
|
23.12 ug/mL
Geometric Coefficient of Variation 21.10
|
35.42 ug/mL
Geometric Coefficient of Variation 39.20
|
32.30 ug/mL
Geometric Coefficient of Variation 22.08
|
55.53 ug/mL
Geometric Coefficient of Variation 10.31
|
29.1 ug/mL
Geometric Coefficient of Variation 34.1
|
4.78 ug/mL
Geometric Coefficient of Variation 12.35
|
12.20 ug/mL
Geometric Coefficient of Variation 9.47
|
19.81 ug/mL
Geometric Coefficient of Variation 17.32
|
34.67 ug/mL
Geometric Coefficient of Variation 18.48
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Part: Maximum Observed Plasma Concentration (Cmax) of Tisotumab Vedotin and Total HuMax-TF
Tisotumab Vedotin: Cycle 2
|
21.84 ug/mL
Geometric Coefficient of Variation 24.97
|
35.92 ug/mL
Geometric Coefficient of Variation 30.39
|
44.30 ug/mL
Geometric Coefficient of Variation 0.32
|
48.79 ug/mL
Geometric Coefficient of Variation 26.37
|
26.1 ug/mL
Geometric Coefficient of Variation 41.2
|
3.85 ug/mL
Geometric Coefficient of Variation 27.65
|
12.51 ug/mL
Geometric Coefficient of Variation 11.51
|
20.25 ug/mL
Geometric Coefficient of Variation 5.14
|
32.38 ug/mL
Geometric Coefficient of Variation 7.11
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Part: Maximum Observed Plasma Concentration (Cmax) of Tisotumab Vedotin and Total HuMax-TF
Total HuMax-TF: Cycle 1
|
23.55 ug/mL
Geometric Coefficient of Variation 25.16
|
30.57 ug/mL
Geometric Coefficient of Variation 37.42
|
38.78 ug/mL
Geometric Coefficient of Variation 21.77
|
58.02 ug/mL
Geometric Coefficient of Variation 12.77
|
39.8 ug/mL
Geometric Coefficient of Variation 31.1
|
4.90 ug/mL
Geometric Coefficient of Variation 13.00
|
11.84 ug/mL
Geometric Coefficient of Variation 8.31
|
17.98 ug/mL
Geometric Coefficient of Variation 11.64
|
29.30 ug/mL
Geometric Coefficient of Variation 10.14
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Part: Maximum Observed Plasma Concentration (Cmax) of Tisotumab Vedotin and Total HuMax-TF
Total HuMax-TF: Cycle 2
|
22.11 ug/mL
Geometric Coefficient of Variation 21.03
|
37.71 ug/mL
Geometric Coefficient of Variation 42.96
|
43.40 ug/mL
Geometric Coefficient of Variation 6.67
|
53.67 ug/mL
Geometric Coefficient of Variation 19.75
|
38.3 ug/mL
Geometric Coefficient of Variation 33.3
|
3.96 ug/mL
Geometric Coefficient of Variation 21.83
|
11.54 ug/mL
Geometric Coefficient of Variation 8.83
|
16.90 ug/mL
Geometric Coefficient of Variation 1.57
|
31.33 ug/mL
Geometric Coefficient of Variation 8.13
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)Population: PK analysis set: all participants who had been exposed to tisotumab vedotin and had at least 1 PK assessment after first dose.
PK parameters in plasma were determined based on non-compartmental methods and calculated separately for Cycle 1 and Cycle 2 in each part of the study.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
n=168 Participants
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Part: Time of Cmax (Tmax) of Tisotumab Vedotin and Total HuMax-TF
Total HuMax-TF: Cycle 2
|
1.21 hours
Geometric Coefficient of Variation 16.61
|
1.76 hours
Geometric Coefficient of Variation 50.43
|
1.14 hours
Geometric Coefficient of Variation 9.29
|
1.29 hours
Geometric Coefficient of Variation 7.55
|
1.15 hours
Geometric Coefficient of Variation 356.23
|
2.19 hours
Geometric Coefficient of Variation 46.56
|
1.34 hours
Geometric Coefficient of Variation 6.27
|
1.32 hours
Geometric Coefficient of Variation 5.96
|
1.13 hours
Geometric Coefficient of Variation 11.18
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Part: Time of Cmax (Tmax) of Tisotumab Vedotin and Total HuMax-TF
Tisotumab Vedotin: Cycle 1
|
1.12 hours
Geometric Coefficient of Variation 9.55
|
1.18 hours
Geometric Coefficient of Variation 14.30
|
1.18 hours
Geometric Coefficient of Variation 7.45
|
1.11 hours
Geometric Coefficient of Variation 12.52
|
1.21 hours
Geometric Coefficient of Variation 364.12
|
1.47 hours
Geometric Coefficient of Variation 72.74
|
1.18 hours
Geometric Coefficient of Variation 13.03
|
1.34 hours
Geometric Coefficient of Variation 11.77
|
1.15 hours
Geometric Coefficient of Variation 11.66
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Part: Time of Cmax (Tmax) of Tisotumab Vedotin and Total HuMax-TF
Tisotumab Vedotin: Cycle 2
|
1.21 hours
Geometric Coefficient of Variation 16.61
|
2.44 hours
Geometric Coefficient of Variation 35.75
|
1.14 hours
Geometric Coefficient of Variation 9.29
|
1.29 hours
Geometric Coefficient of Variation 7.55
|
1.44 hours
Geometric Coefficient of Variation 303.89
|
1.54 hours
Geometric Coefficient of Variation 63.29
|
1.34 hours
Geometric Coefficient of Variation 6.27
|
1.32 hours
Geometric Coefficient of Variation 5.96
|
1.13 hours
Geometric Coefficient of Variation 11.18
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Part: Time of Cmax (Tmax) of Tisotumab Vedotin and Total HuMax-TF
Total HuMax-TF: Cycle 1
|
1.12 hours
Geometric Coefficient of Variation 9.55
|
1.18 hours
Geometric Coefficient of Variation 14.30
|
1.18 hours
Geometric Coefficient of Variation 7.45
|
1.11 hours
Geometric Coefficient of Variation 12.52
|
1.10 hours
Geometric Coefficient of Variation 397.92
|
2.20 hours
Geometric Coefficient of Variation 49.15
|
1.18 hours
Geometric Coefficient of Variation 13.03
|
1.34 hours
Geometric Coefficient of Variation 11.77
|
1.15 hours
Geometric Coefficient of Variation 11.66
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)Population: PK analysis set: all participants who had been exposed to tisotumab vedotin and had at least 1 PK assessment after first dose.
PK parameters in plasma were determined based on non-compartmental methods and calculated separately for Cycle 1 and Cycle 2. t1/2 was only analyzed for the dose escalation part of the study. Data was not planned to be collected for t1/2 of tisotumab vedotin and total HuMax-TF for the dose expansion part.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Part: Half-life (t1/2) of Tisotumab Vedotin and Total HuMax-TF
Tisotumab Vedotin: Cycle 1
|
32.42 hours
Geometric Coefficient of Variation 20.05
|
47.89 hours
Geometric Coefficient of Variation 25.82
|
40.93 hours
Geometric Coefficient of Variation 11.48
|
41.19 hours
Geometric Coefficient of Variation 34.02
|
—
|
12.22 hours
Geometric Coefficient of Variation 11.61
|
29.53 hours
Geometric Coefficient of Variation 4.08
|
33.72 hours
Geometric Coefficient of Variation 6.26
|
41.06 hours
Geometric Coefficient of Variation 6.85
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Half-life (t1/2) of Tisotumab Vedotin and Total HuMax-TF
Tisotumab Vedotin: Cycle 2
|
33.62 hours
Geometric Coefficient of Variation 14.50
|
32.15 hours
Geometric Coefficient of Variation 62.74
|
39.89 hours
Geometric Coefficient of Variation 23.15
|
48.93 hours
Geometric Coefficient of Variation 5.61
|
—
|
13.54 hours
Geometric Coefficient of Variation 5.50
|
23.50 hours
Geometric Coefficient of Variation 39.89
|
33.68 hours
Geometric Coefficient of Variation 1.74
|
40.44 hours
Geometric Coefficient of Variation 4.69
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Half-life (t1/2) of Tisotumab Vedotin and Total HuMax-TF
Total HuMax-TF: Cycle 1
|
42.72 hours
Geometric Coefficient of Variation 34.62
|
57.72 hours
Geometric Coefficient of Variation 17.47
|
54.95 hours
Geometric Coefficient of Variation 5.32
|
55.10 hours
Geometric Coefficient of Variation 27.36
|
—
|
16.05 hours
Geometric Coefficient of Variation 27.93
|
28.66 hours
Geometric Coefficient of Variation 30.64
|
42.52 hours
Geometric Coefficient of Variation 7.48
|
57.37 hours
Geometric Coefficient of Variation 8.65
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: Half-life (t1/2) of Tisotumab Vedotin and Total HuMax-TF
Total HuMax-TF: Cycle 2
|
42.18 hours
Geometric Coefficient of Variation 25.39
|
46.24 hours
Geometric Coefficient of Variation 53.11
|
51.06 hours
Geometric Coefficient of Variation 9.18
|
66.05 hours
Geometric Coefficient of Variation 10.07
|
—
|
18.34 hours
Geometric Coefficient of Variation 8.73
|
30.71 hours
Geometric Coefficient of Variation 27.65
|
40.37 hours
Geometric Coefficient of Variation 4.27
|
56.77 hours
Geometric Coefficient of Variation 9.60
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)Population: PK analysis set: all participants who had been exposed to tisotumab vedotin and had at least 1 PK assessment after first dose.
PK parameters in plasma were determined based on non compartmental methods and calculated separately for Cycle 1 and Cycle 2 in each part of the study.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
n=168 Participants
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Part: AUC0-t of Free Monomethyl Auristatin E (MMAE)
Cycle 2
|
21.51 day*ng/mL
Geometric Coefficient of Variation 34.25
|
18.97 day*ng/mL
Geometric Coefficient of Variation 52.14
|
36.20 day*ng/mL
Geometric Coefficient of Variation 33.82
|
37.50 day*ng/mL
Geometric Coefficient of Variation 43.08
|
23.48 day*ng/mL
Geometric Coefficient of Variation 76.47
|
3.19 day*ng/mL
Geometric Coefficient of Variation 140.85
|
4.69 day*ng/mL
Geometric Coefficient of Variation 87.27
|
14.89 day*ng/mL
Geometric Coefficient of Variation 66.97
|
16.92 day*ng/mL
Geometric Coefficient of Variation 58.12
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Part: AUC0-t of Free Monomethyl Auristatin E (MMAE)
Cycle 1
|
26.55 day*ng/mL
Geometric Coefficient of Variation 44.24
|
22.55 day*ng/mL
Geometric Coefficient of Variation 57.26
|
67.42 day*ng/mL
Geometric Coefficient of Variation 59.98
|
26.47 day*ng/mL
Geometric Coefficient of Variation 59.35
|
25.80 day*ng/mL
Geometric Coefficient of Variation 93.91
|
6.20 day*ng/mL
Geometric Coefficient of Variation 72.05
|
12.61 day*ng/mL
Geometric Coefficient of Variation 28.18
|
12.22 day*ng/mL
Geometric Coefficient of Variation 67.23
|
11.63 day*ng/mL
Geometric Coefficient of Variation 52.69
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)Population: PK analysis set: all participants who had been exposed to tisotumab vedotin and had at least 1 PK assessment after first dose
PK parameters in plasma were determined based on non-compartmental methods and calculated separately for Cycle 1 and Cycle 2. AUC0-inf was not planned to be collected for the dose expansion part. AUC0-inf was not calculated where the percentage of the AUC that was due to the extrapolation was more than 20%.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=2 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=1 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=1 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=1 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=2 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=1 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=2 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=1 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Part: AUC0-inf of Free MMAE
Cycle 1
|
27.08 day*ng/mL
Geometric Coefficient of Variation 58.96
|
25.29 day*ng/mL
Geometric Coefficient of Variation NA
Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
|
78.31 day*ng/mL
Geometric Coefficient of Variation NA
Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
|
63.03 day*ng/mL
Geometric Coefficient of Variation NA
Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
|
—
|
12.63 day*ng/mL
Geometric Coefficient of Variation 12.44
|
13.93 day*ng/mL
Geometric Coefficient of Variation NA
Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
|
16.32 day*ng/mL
Geometric Coefficient of Variation 57.56
|
20.39 day*ng/mL
Geometric Coefficient of Variation NA
Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: AUC0-inf of Free MMAE
Cycle 2
|
31.43 day*ng/mL
Geometric Coefficient of Variation NA
Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
|
33.23 day*ng/mL
Geometric Coefficient of Variation NA
Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
|
—
|
58.95 day*ng/mL
Geometric Coefficient of Variation NA
Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
|
—
|
—
|
—
|
22.32 day*ng/mL
Geometric Coefficient of Variation 43.62
|
31.40 day*ng/mL
Geometric Coefficient of Variation NA
Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)Population: PK analysis set: all participants who had been exposed to tisotumab vedotin and had at least 1 PK assessment after first dose
PK parameters in plasma were determined based on non-compartmental methods and calculated separately for Cycle 1 and Cycle 2 in each part of the study.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
n=168 Participants
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Part: Cmax of Free MMAE
Cycle 1
|
2.807 ng/mL
Geometric Coefficient of Variation 39.398
|
2.587 ng/mL
Geometric Coefficient of Variation 29.172
|
6.351 ng/mL
Geometric Coefficient of Variation 61.505
|
4.877 ng/mL
Geometric Coefficient of Variation 31.350
|
3.16 ng/mL
Geometric Coefficient of Variation 88.30
|
0.760 ng/mL
Geometric Coefficient of Variation 62.505
|
1.673 ng/mL
Geometric Coefficient of Variation 30.756
|
1.524 ng/mL
Geometric Coefficient of Variation 54.491
|
1.410 ng/mL
Geometric Coefficient of Variation 19.149
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Part: Cmax of Free MMAE
Cycle 2
|
2.718 ng/mL
Geometric Coefficient of Variation 39.492
|
2.035 ng/mL
Geometric Coefficient of Variation 39.785
|
3.369 ng/mL
Geometric Coefficient of Variation 36.875
|
4.704 ng/mL
Geometric Coefficient of Variation 18.856
|
2.73 ng/mL
Geometric Coefficient of Variation 78.69
|
1.091 ng/mL
Geometric Coefficient of Variation 74.293
|
1.342 ng/mL
Geometric Coefficient of Variation 24.320
|
2.059 ng/mL
Geometric Coefficient of Variation 51.470
|
2.243 ng/mL
Geometric Coefficient of Variation 50.367
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)Population: PK analysis set: all participants who had been exposed to tisotumab vedotin and had at least 1 PK assessment after first dose.
PK parameters in plasma were determined based on non-compartmental methods and calculated separately for Cycle 1 and Cycle 2 in each part of the study.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
n=168 Participants
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Part: Tmax of Free MMAE
Cycle 1
|
25.07 hours
Geometric Coefficient of Variation 0.68
|
47.74 hours
Geometric Coefficient of Variation 114.28
|
83.24 hours
Geometric Coefficient of Variation 67.57
|
84.88 hours
Geometric Coefficient of Variation 61.54
|
154.28 hours
Geometric Coefficient of Variation 54.214
|
23.88 hours
Geometric Coefficient of Variation 4.41
|
22.77 hours
Geometric Coefficient of Variation 16.56
|
24.39 hours
Geometric Coefficient of Variation 7.72
|
24.19 hours
Geometric Coefficient of Variation 5.52
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation and Expansion Part: Tmax of Free MMAE
Cycle 2
|
25.26 hours
Geometric Coefficient of Variation 0.76
|
46.24 hours
Geometric Coefficient of Variation 112.48
|
65.15 hours
Geometric Coefficient of Variation 104.61
|
47.12 hours
Geometric Coefficient of Variation 112.10
|
125.38 hours
Geometric Coefficient of Variation 31.21
|
23.73 hours
Geometric Coefficient of Variation 5.78
|
24.05 hours
Geometric Coefficient of Variation 8.48
|
23.92 hours
Geometric Coefficient of Variation 13.04
|
24.94 hours
Geometric Coefficient of Variation 1.48
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)Population: PK analysis set: all participants who had been exposed to tisotumab vedotin and had at least 1 PK assessment after first dose.
PK parameters in plasma were determined based on non compartmental methods and calculated separately for Cycle 1 and Cycle 2. T1/2 was determined only for the dose escalation part of the study.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=2 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=1 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=1 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=1 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=2 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=1 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=2 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=1 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Part: PK Parameters, T 1/2 of Free MMAE
Cycle 1
|
63.65 hours
Geometric Coefficient of Variation 7.86
|
78.90 hours
Geometric Coefficient of Variation NA
Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
|
57.74 hours
Geometric Coefficient of Variation NA
Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
|
68.47 hours
Geometric Coefficient of Variation NA
Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
|
—
|
95.15 hours
Geometric Coefficient of Variation 25.74
|
69.34 hours
Geometric Coefficient of Variation NA
Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
|
63.98 hours
Geometric Coefficient of Variation 2.24
|
62.58 hours
Geometric Coefficient of Variation NA
Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation Part: PK Parameters, T 1/2 of Free MMAE
Cycle 2
|
70.20 hours
Geometric Coefficient of Variation NA
Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
|
78.94 hours
Geometric Coefficient of Variation NA
Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
|
—
|
63.92 hours
Geometric Coefficient of Variation NA
Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
|
—
|
—
|
—
|
69.65 hours
Geometric Coefficient of Variation 3.86
|
60.71 hours
Geometric Coefficient of Variation NA
Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to end of follow-up, up to a maximum of 60 weeksPopulation: Full analysis set: all participants who had been exposed to tisotumab vedotin in either the dose escalation or expansion parts.
Participants who met the criterion for positive ADAs on treatment were defined as participants who were negative at baseline and had at least one positive post-baseline result, or participants who were positive at baseline and had at least one post baseline result with a titer higher than baseline.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
n=15 Participants
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
n=55 Participants
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
n=14 Participants
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
n=15 Participants
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
n=15 Participants
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
n=36 Participants
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
n=18 Participants
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Part: Number of Participants With Positive Anti-Drug Antibodies (ADAs) to Tisotumab Vedotin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to end of follow-up, up to a maximum of 60 weeksPopulation: Full analysis set: all participants who had been exposed to tisotumab vedotin in the dose escalation part.
Anti-tumor activity measured by the number of participants who experienced tumor shrinkage was not planned to be collected for the dose expansion part.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Part: Anti-Tumor Activity Measured by Number of Participants Who Experienced Tumor Shrinkage
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to end of follow-up, up to a maximum of 60 weeksPopulation: The number of participants analyzed includes all participants with baseline and one post-baseline evaluable tumor assessment
Anti-tumor activity measured by maximum reduction among available post-baseline sum of lesion measurements was not planned to be collected for the dose escalation part.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=14 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=33 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=12 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=14 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=50 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=12 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=11 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Part: Anti-Tumor Activity Measured by Maximum Reduction Among Available Post-Baseline Sum of Lesion Measurements
|
0.00 millimeter(s)
Interval -59.0 to 31.0
|
-4.00 millimeter(s)
Interval -41.0 to 115.0
|
-1.00 millimeter(s)
Interval -11.0 to 15.0
|
—
|
—
|
6.00 millimeter(s)
Interval -127.0 to 41.0
|
-8.50 millimeter(s)
Interval -64.0 to 50.0
|
1.00 millimeter(s)
Interval -11.0 to 26.0
|
-2.00 millimeter(s)
Interval -51.0 to 40.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to end of follow-up, up to a maximum of 60 weeksPopulation: Analyses includes all participants with castrate-resistant prostate cancer who have a baseline and end of study evaluable assessment.
PSA was only assessed in participants with castrate-resistant prostate cancer.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=1 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
n=11 Participants
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=1 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=1 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Part: Percentage Change From Baseline in Prostate Specific Antigen (PSA)
|
3.92 Percentage Change in PSA
Interval 3.92 to 3.92
|
—
|
—
|
—
|
60.07 Percentage Change in PSA
Interval 3.4 to 996.5
|
—
|
64.35 Percentage Change in PSA
Interval 64.35 to 64.35
|
—
|
40.91 Percentage Change in PSA
Interval 40.91 to 40.91
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to end of follow-up, up to a maximum of 60 weeksPopulation: Analyses includes all participants in the dose escalation and expansion parts with ovarian cancer and some participants with NSCLC and cervical cancer in the dose expansion part who have a baseline and end of study evaluable assessment.
In the dose escalation part, CA-125 was only assessed for participants with ovarian cancer. In the dose expansion part, CA-125 was intended to be assessed only for participants with ovarian and endometrium cancer, but was additionally assessed for some participants with NSCLC and cervical cancer.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=1 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=1 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=2 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
n=8 Participants
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=1 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
n=10 Participants
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
n=3 Participants
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
n=25 Participants
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Part: Percentage Change From Baseline in CA-125
|
—
|
-13.98 Percentage Change
Interval -13.98 to -13.98
|
113.71 Percentage Change
Interval 113.71 to 113.71
|
11.62 Percentage Change
Interval -22.7 to 45.9
|
-25.17 Percentage Change
Interval -88.7 to 240.5
|
—
|
—
|
—
|
18.75 Percentage Change
Interval 18.75 to 18.75
|
37.85 Percentage Change
Interval -46.1 to 666.2
|
180.94 Percentage Change
Interval 47.1 to 980.5
|
73.19 Percentage Change
Interval -89.0 to 1924.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to end of follow-up, up to a maximum of 60 weeksPopulation: Full analysis set: all participants who had been exposed to tisotumab vedotin in either the dose escalation or expansion parts.
Objective Response Rate per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Response assessment was investigator based for the escalation part and Independent Review Committee (IRC) based for the expansion part.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
n=15 Participants
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
n=55 Participants
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
n=14 Participants
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
n=15 Participants
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
n=15 Participants
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
n=36 Participants
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
n=18 Participants
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Part: Objective Response Rate
|
0 Percentage of Participants
Interval 0.0 to 71.0
|
0 Percentage of Participants
Interval 0.0 to 71.0
|
0 Percentage of Participants
Interval 0.0 to 71.0
|
0 Percentage of Participants
Interval 0.0 to 46.0
|
27 Percentage of Participants
Interval 8.0 to 55.0
|
0 Percentage of Participants
Interval 0.0 to 71.0
|
0 Percentage of Participants
Interval 0.0 to 71.0
|
0 Percentage of Participants
Interval 0.0 to 71.0
|
33 Percentage of Participants
Interval 1.0 to 91.0
|
24 Percentage of Participants
Interval 13.0 to 37.0
|
7 Percentage of Participants
Interval 0.0 to 34.0
|
13 Percentage of Participants
Interval 2.0 to 40.0
|
13 Percentage of Participants
Interval 2.0 to 40.0
|
14 Percentage of Participants
Interval 5.0 to 29.0
|
0 Percentage of Participants
Interval 0.0 to 19.0
|
SECONDARY outcome
Timeframe: At 6, 12, 24 and 36 weeksPopulation: Full analysis set: all participants who had been exposed to tisotumab vedotin in either the dose escalation or expansion parts.
Disease control rate was defined as the percentage of participants with CR, PR or stable disease (SD) as per investigator assessment per RECIST version 1.1 after 6, 12, 24 and 36 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
n=15 Participants
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
n=55 Participants
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
n=14 Participants
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
n=15 Participants
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
n=15 Participants
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
n=36 Participants
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
n=18 Participants
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Part: Disease Control Rate
Week 6
|
33 Percentage of Participants
Interval 1.0 to 91.0
|
100 Percentage of Participants
Interval 29.0 to 100.0
|
67 Percentage of Participants
Interval 9.0 to 99.0
|
50 Percentage of Participants
Interval 12.0 to 88.0
|
47 Percentage of Participants
Interval 21.0 to 73.0
|
0 Percentage of Participants
Interval 0.0 to 71.0
|
33 Percentage of Participants
Interval 1.0 to 91.0
|
33 Percentage of Participants
Interval 1.0 to 91.0
|
67 Percentage of Participants
Interval 9.0 to 99.0
|
60 Percentage of Participants
Interval 46.0 to 73.0
|
64 Percentage of Participants
Interval 35.0 to 87.0
|
40 Percentage of Participants
Interval 16.0 to 68.0
|
60 Percentage of Participants
Interval 32.0 to 84.0
|
72 Percentage of Participants
Interval 55.0 to 86.0
|
61 Percentage of Participants
Interval 36.0 to 83.0
|
|
Dose Escalation and Expansion Part: Disease Control Rate
Week 12
|
0 Percentage of Participants
Interval 0.0 to 71.0
|
67 Percentage of Participants
Interval 9.0 to 99.0
|
33 Percentage of Participants
Interval 1.0 to 91.0
|
0 Percentage of Participants
Interval 0.0 to 46.0
|
33 Percentage of Participants
Interval 12.0 to 62.0
|
0 Percentage of Participants
Interval 0.0 to 71.0
|
33 Percentage of Participants
Interval 1.0 to 91.0
|
33 Percentage of Participants
Interval 1.0 to 91.0
|
67 Percentage of Participants
Interval 9.0 to 99.0
|
47 Percentage of Participants
Interval 34.0 to 61.0
|
43 Percentage of Participants
Interval 18.0 to 71.0
|
20 Percentage of Participants
Interval 4.0 to 48.0
|
13 Percentage of Participants
Interval 2.0 to 40.0
|
42 Percentage of Participants
Interval 26.0 to 59.0
|
28 Percentage of Participants
Interval 10.0 to 53.0
|
|
Dose Escalation and Expansion Part: Disease Control Rate
Week 24
|
0 Percentage of Participants
Interval 0.0 to 71.0
|
0 Percentage of Participants
Interval 0.0 to 71.0
|
0 Percentage of Participants
Interval 0.0 to 71.0
|
0 Percentage of Participants
Interval 0.0 to 46.0
|
20 Percentage of Participants
Interval 4.0 to 48.0
|
0 Percentage of Participants
Interval 0.0 to 71.0
|
33 Percentage of Participants
Interval 1.0 to 91.0
|
0 Percentage of Participants
Interval 0.0 to 71.0
|
33 Percentage of Participants
Interval 1.0 to 91.0
|
18 Percentage of Participants
Interval 9.0 to 31.0
|
21 Percentage of Participants
Interval 5.0 to 51.0
|
7 Percentage of Participants
Interval 0.0 to 32.0
|
13 Percentage of Participants
Interval 2.0 to 40.0
|
14 Percentage of Participants
Interval 5.0 to 29.0
|
6 Percentage of Participants
Interval 0.0 to 27.0
|
|
Dose Escalation and Expansion Part: Disease Control Rate
Week 36
|
0 Percentage of Participants
Interval 0.0 to 71.0
|
0 Percentage of Participants
Interval 0.0 to 71.0
|
0 Percentage of Participants
Interval 0.0 to 71.0
|
0 Percentage of Participants
Interval 0.0 to 46.0
|
7 Percentage of Participants
Interval 0.0 to 32.0
|
0 Percentage of Participants
Interval 0.0 to 71.0
|
33 Percentage of Participants
Interval 1.0 to 91.0
|
0 Percentage of Participants
Interval 0.0 to 71.0
|
33 Percentage of Participants
Interval 1.0 to 91.0
|
11 Percentage of Participants
Interval 4.0 to 22.0
|
0 Percentage of Participants
Interval 0.0 to 23.0
|
0 Percentage of Participants
Interval 0.0 to 22.0
|
7 Percentage of Participants
Interval 0.0 to 32.0
|
3 Percentage of Participants
Interval 0.0 to 15.0
|
6 Percentage of Participants
Interval 0.0 to 27.0
|
SECONDARY outcome
Timeframe: Day 1 to end of follow-up, up to a maximum of 60 weeksPopulation: Participants with documented disease progression and/or death are included.
PFS was defined as the time in weeks from Day 1 in Cycle 1 to first disease progression or death, whichever occurred earliest, as assessed by the investigator. Only deaths that occurred within 60 days of the last visit were considered in the analysis and result are presented based on Kaplan-Meier estimates. Progression as defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase from nadir in the sum of diameters of target lesions, unequivocal progression in non-target lesions, or the appearance of new lesions
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=2 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
n=10 Participants
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=2 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=2 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
n=41 Participants
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
n=4 Participants
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
n=10 Participants
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
n=9 Participants
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
n=26 Participants
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
n=12 Participants
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Expansion Part: Progression Free Survival (PFS)
|
6.1 Weeks
Interval 5.3 to 10.4
|
17.1 Weeks
Interval 11.3 to
Upper limit was not estimable because of insufficient number of participants with events prior to censoring
|
12.3 Weeks
Interval 5.0 to 14.1
|
11.3 Weeks
Interval 2.1 to 11.3
|
11.0 Weeks
Interval 5.1 to 43.0
|
5.1 Weeks
Interval 4.9 to 5.4
|
6.0 Weeks
Interval 3.9 to 49.1
|
6.1 Weeks
Interval 4.9 to
Upper limit was not estimable because of insufficient number of participants with events prior to censoring.
|
27.1 Weeks
Interval 6.0 to
Upper limit was not estimable because of insufficient number of participants with events prior to censoring.
|
18.1 Weeks
Interval 9.3 to 23.0
|
NA Weeks
Interval 5.1 to
Median and upper limit were not estimable because of insufficient number of participants with events prior to censoring.
|
10.1 Weeks
Interval 5.3 to 17.0
|
13.0 Weeks
Interval 5.1 to 17.3
|
13.0 Weeks
Interval 12.1 to 18.3
|
12.9 Weeks
Interval 7.1 to 23.7
|
SECONDARY outcome
Timeframe: Day 1 to end of follow-up, up to a maximum of 60 weeksPopulation: All participants who had a confirmed response of either CR or PR and were considered a responder for the study.
DOR was defined as the median time in weeks from when confirmed response was first documented until the first documented disease progression, or death from any cause, whichever was earliest as assessed by the investigator. A responder was defined as any participant with a best overall response of confirmed CR or PR.
Outcome measures
| Measure |
Dose Escalation Part: 1.5 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
n=4 Participants
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study.
|
Dose Escalation Part: 0.3 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=1 Participants
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
n=13 Participants
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
n=1 Participants
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
n=2 Participants
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small Cell Lung Cancer (NSCLC)
n=2 Participants
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
n=5 Participants
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Part: Duration of Response (DOR)
|
—
|
—
|
—
|
—
|
32.0 Weeks
Interval 11.0 to 32.0
|
—
|
—
|
—
|
NA Weeks
Duration of response could not be estimated because DOR was censored for the single responder.
|
18.4 Weeks
Interval 13.1 to 41.7
|
NA Weeks
Duration of response could not be estimated because DOR was censored for the single responder.
|
18.3 Weeks
Interval 11.6 to 25.0
|
NA Weeks
Interval 12.0 to
Duration of response and the upper CI limit could not be estimated because DOR for one responder was censored later than the observed DOR for the other responder.
|
21.4 Weeks
Interval 13.1 to 29.6
|
—
|
Adverse Events
Dose Escalation Part: 0.3 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Dose Escalation Part: 0.6 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Escalation Part: 0.9 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Escalation Part: 1.2 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Escalation Part: 1.5 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Escalation Part: 1.8 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Escalation Part: 2.0 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Escalation Part: 2.2 mg/kg
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Expansion Part: Bladder Cancer
Serious events: 7 serious events
Other events: 15 other events
Deaths: 0 deaths
Dose Expansion Part: Cervical Cancer
Serious events: 26 serious events
Other events: 55 other events
Deaths: 2 deaths
Dose Expansion Part: Endometrial Cancer
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
Dose Expansion Part: Esophageal Cancer
Serious events: 8 serious events
Other events: 15 other events
Deaths: 1 deaths
Dose Expansion Part: Non-Small-Cell Lung Cancer
Serious events: 6 serious events
Other events: 15 other events
Deaths: 1 deaths
Dose Expansion Part: Ovarian Cancer
Serious events: 13 serious events
Other events: 36 other events
Deaths: 2 deaths
Dose Expansion Part: Prostate Cancer
Serious events: 6 serious events
Other events: 18 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dose Escalation Part: 0.3 mg/kg
n=3 participants at risk
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 participants at risk
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 participants at risk
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 participants at risk
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Escalation Part: 1.5 mg/kg
n=3 participants at risk
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 participants at risk
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 participants at risk
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 participants at risk
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Bladder Cancer
n=15 participants at risk
Participants with bladder cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
n=55 participants at risk
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
n=14 participants at risk
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
n=15 participants at risk
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small-Cell Lung Cancer
n=15 participants at risk
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
n=36 participants at risk
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
n=18 participants at risk
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.3%
4/55 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Catheter site pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
2/6 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
3.6%
2/55 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
3.6%
2/55 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
2.8%
1/36 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
3.6%
2/55 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
2.8%
1/36 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
2.8%
1/36 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
3.6%
2/55 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
2.8%
1/36 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
2.8%
1/36 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
2.8%
1/36 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
2.8%
1/36 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
2.8%
1/36 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Kidney infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
2.8%
1/36 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Micrococcus infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Cystitis escherichia
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Malaise
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
3.6%
2/55 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
2.8%
1/36 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Fatigue
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
2.8%
1/36 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Guillain-barre syndrome
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
2.8%
1/36 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
2.8%
1/36 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
3.6%
2/55 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
2.8%
1/36 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
2.8%
1/36 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
11.1%
2/18 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
66.7%
2/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
3.6%
2/55 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
3.6%
2/55 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
2.8%
1/36 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Product Issues
Stent malfunction
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Vascular disorders
Vascular disorders
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
Other adverse events
| Measure |
Dose Escalation Part: 0.3 mg/kg
n=3 participants at risk
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
|
Dose Escalation Part: 0.6 mg/kg
n=3 participants at risk
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
|
Dose Escalation Part: 0.9 mg/kg
n=3 participants at risk
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
|
Dose Escalation Part: 1.2 mg/kg
n=3 participants at risk
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
|
Dose Escalation Part: 1.5 mg/kg
n=3 participants at risk
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
|
Dose Escalation Part: 1.8 mg/kg
n=3 participants at risk
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
|
Dose Escalation Part: 2.0 mg/kg
n=3 participants at risk
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Escalation Part: 2.2 mg/kg
n=6 participants at risk
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
|
Dose Expansion Part: Bladder Cancer
n=15 participants at risk
Participants with bladder cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Cervical Cancer
n=55 participants at risk
Participants with cervical cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Endometrial Cancer
n=14 participants at risk
Participants with endometrial cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Esophageal Cancer
n=15 participants at risk
Participants with esophageal cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Non-Small-Cell Lung Cancer
n=15 participants at risk
Participants with NSCLC received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Ovarian Cancer
n=36 participants at risk
Participants with ovarian cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
Dose Expansion Part: Prostate Cancer
n=18 participants at risk
Participants with prostate cancer received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Central pain syndrome
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal crusting
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
2/6 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
3.6%
2/55 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
10.9%
6/55 • Number of events 7 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
8.3%
3/36 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.3%
4/55 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
11.1%
2/18 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Injury, poisoning and procedural complications
Conjunctival scar
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Injury, poisoning and procedural complications
Eyelid contusion
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Injury, poisoning and procedural complications
Pharynx radiation injury
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Injury, poisoning and procedural complications
Chemical burns of eye
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.9%
5/36 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.3%
4/55 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
2/6 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
9.1%
5/55 • Number of events 7 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
3/18 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
4/6 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
46.7%
7/15 • Number of events 7 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
45.5%
25/55 • Number of events 30 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
50.0%
7/14 • Number of events 8 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
46.7%
7/15 • Number of events 8 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
10/15 • Number of events 16 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
55.6%
20/36 • Number of events 30 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
12/18 • Number of events 14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
2/3 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
50.0%
3/6 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
40.0%
6/15 • Number of events 7 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
34.5%
19/55 • Number of events 21 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
21.4%
3/14 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
40.0%
6/15 • Number of events 8 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
5/15 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
30.6%
11/36 • Number of events 13 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
50.0%
9/18 • Number of events 11 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
2/3 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
30.9%
17/55 • Number of events 26 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
42.9%
6/14 • Number of events 8 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
26.7%
4/15 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
38.9%
14/36 • Number of events 19 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
27.8%
5/18 • Number of events 7 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
2/6 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
32.7%
18/55 • Number of events 23 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
28.6%
4/14 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
26.7%
4/15 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
40.0%
6/15 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
30.6%
11/36 • Number of events 18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
6/18 • Number of events 9 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
27.3%
15/55 • Number of events 17 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
22.2%
8/36 • Number of events 9 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
6/18 • Number of events 8 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
14.3%
2/14 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
11.1%
4/36 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.5%
3/55 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
35.7%
5/14 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
2/3 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
6/36 • Number of events 7 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
11.1%
2/18 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.5%
3/55 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.5%
3/55 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
8.3%
3/36 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
26.7%
4/15 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
14.3%
2/14 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Oesophageal mucosal hyperplasia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
100.0%
3/3 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
2/3 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
100.0%
3/3 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
2/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
4/6 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
86.7%
13/15 • Number of events 13 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
50.9%
28/55 • Number of events 40 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
78.6%
11/14 • Number of events 13 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
53.3%
8/15 • Number of events 10 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
73.3%
11/15 • Number of events 15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
83.3%
30/36 • Number of events 34 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
12/18 • Number of events 12 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
14.5%
8/55 • Number of events 8 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
21.4%
3/14 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
6/36 • Number of events 7 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
11.1%
2/18 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
9.1%
5/55 • Number of events 8 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
5/15 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
8.3%
3/36 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
2/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
9.1%
5/55 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
11.1%
4/36 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
14.3%
2/14 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
6/36 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
8.3%
3/36 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
8.3%
3/36 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
100.0%
3/3 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
4/6 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
53.3%
8/15 • Number of events 10 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
52.7%
29/55 • Number of events 34 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
71.4%
10/14 • Number of events 12 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
10/15 • Number of events 10 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
53.3%
8/15 • Number of events 11 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
41.7%
15/36 • Number of events 18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
83.3%
15/18 • Number of events 16 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Pyrexia
|
66.7%
2/3 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
4/6 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
11/55 • Number of events 13 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
11.1%
4/36 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Mucosal inflammation
|
33.3%
1/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
9.1%
5/55 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
14.3%
2/14 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.9%
5/36 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Chills
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
14.3%
2/14 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Malaise
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.9%
5/36 • Number of events 7 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Asthenia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
8.3%
3/36 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Chest pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
11.1%
2/18 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Influenza like illness
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
14.3%
2/14 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Face oedema
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Infusion site reaction
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Swelling
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
General disorders
Oedema
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
2/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
2/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
4/6 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
40.0%
22/55 • Number of events 22 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
57.1%
8/14 • Number of events 8 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
26.7%
4/15 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
46.7%
7/15 • Number of events 7 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
52.8%
19/36 • Number of events 19 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
6/18 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
18.2%
10/55 • Number of events 11 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
14.3%
2/14 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
6/36 • Number of events 7 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
12.7%
7/55 • Number of events 8 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
28.6%
4/14 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
6/36 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
22.2%
4/18 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.3%
4/55 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
28.6%
4/14 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
2/6 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.3%
4/55 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.9%
5/36 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
8.3%
3/36 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
2/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
46.7%
7/15 • Number of events 9 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
41.8%
23/55 • Number of events 37 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
42.9%
6/14 • Number of events 8 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
26.7%
4/15 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
40.0%
6/15 • Number of events 7 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
41.7%
15/36 • Number of events 19 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
50.0%
9/18 • Number of events 9 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
2/6 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
11/55 • Number of events 16 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
11.1%
4/36 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
8.3%
3/36 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
11.1%
2/18 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
11.1%
4/36 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
21.4%
3/14 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
8.3%
3/36 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Gingivitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Infections and infestations
Urethritis
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
40.0%
6/15 • Number of events 7 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
29.1%
16/55 • Number of events 19 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
35.7%
5/14 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
27.8%
10/36 • Number of events 12 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
3/18 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
9.1%
5/55 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
14.3%
2/14 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
25.0%
9/36 • Number of events 9 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
9.1%
5/55 • Number of events 7 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
21.4%
3/14 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.9%
5/36 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
3/18 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
3/18 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Nervous system disorders
Amputation stump pain
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
83.3%
5/6 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
36.4%
20/55 • Number of events 22 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
35.7%
5/14 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
40.0%
6/15 • Number of events 7 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
5/15 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
12/36 • Number of events 13 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
55.6%
10/18 • Number of events 14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
2/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
2/6 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
11/55 • Number of events 14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.9%
5/36 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
11.1%
2/18 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
10.9%
6/55 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
11.1%
4/36 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
3.6%
2/55 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
9.1%
5/55 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
25.0%
9/36 • Number of events 9 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
27.8%
5/18 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
2/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
2/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
10.9%
6/55 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
14.3%
2/14 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
6/36 • Number of events 7 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
22.2%
4/18 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
2/6 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
10.9%
6/55 • Number of events 7 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
14.3%
2/14 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
8.3%
3/36 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
27.8%
5/18 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.3%
4/55 • Number of events 7 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
11.1%
4/36 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
11.1%
2/18 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
2/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
14.3%
2/14 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Arthritis climacteric
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
25.5%
14/55 • Number of events 14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
42.9%
6/14 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
40.0%
6/15 • Number of events 7 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
6/36 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
11.1%
2/18 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.9%
5/36 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Blepharitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.3%
4/55 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.9%
5/36 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
6/36 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Conjunctival ulcer
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.3%
4/55 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Keratitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.5%
3/55 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Meibomianitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.9%
5/36 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Noninfective conjunctivitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
8.3%
3/36 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Symblepharon
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
8.3%
3/36 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Conjunctival disorder
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
50.0%
3/6 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Eye pruritus
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Open angle glaucoma
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Eye inflammation
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Eye disorders
Eye irritation
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
2/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
26.7%
4/15 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.4%
9/55 • Number of events 10 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
28.6%
4/14 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
8.3%
3/36 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
6/18 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
2/6 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
10.9%
6/55 • Number of events 9 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
21.4%
3/14 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
11.1%
2/18 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
2/6 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
12.7%
7/55 • Number of events 8 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
21.4%
3/14 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
11.1%
2/18 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.3%
4/55 • Number of events 5 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
21.4%
3/14 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Vital dye staining cornea present
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Blood potassium increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Blood urine present
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Body temperature increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Conjunctival staining
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
2.8%
1/36 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Serum ferritin increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Blood urea decreased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Fibrin d dimer increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Investigations
Neutrophil count increased
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
100.0%
3/3 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
66.7%
2/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
50.0%
3/6 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
23.6%
13/55 • Number of events 17 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
14.3%
2/14 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
3/18 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.5%
3/55 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
8.3%
3/36 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
13.3%
2/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
10.9%
6/55 • Number of events 6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
14.3%
2/14 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
26.7%
4/15 • Number of events 4 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
6/36 • Number of events 7 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
11.1%
2/18 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
20.0%
3/15 • Number of events 3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
2/36 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
5.6%
1/18 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
7.1%
1/14 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Psychiatric disorders
Sleep disorder
|
33.3%
1/3 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
33.3%
1/3 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/6 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/36 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/3 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
6.7%
1/15 • Number of events 2 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/55 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/14 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/15 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
2.8%
1/36 • Number of events 1 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
0.00%
0/18 • Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.
Deaths from all causes are reported from day of enrollment to end of follow up (up to maximum of 60 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All proposed publications and presentations shall be submitted to the sponsor for its review at least 30 days before such presentation or publication is submitted to any third party.
- Publication restrictions are in place
Restriction type: OTHER