Trial Outcomes & Findings for A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy (NCT NCT04071366)
NCT ID: NCT04071366
Last Updated: 2024-03-26
Results Overview
The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 2 CRS: temperature ≥38°C not attributable to any other cause, defined as fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressin, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at \>6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., continuous positive airway pressure \[CPAP\], bilevel intermittent positive air pressure \[BiPAP\], intubation, mechanical ventilation).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
112 participants
Primary outcome timeframe
up to Day 14 of Parts 1 and 2
Results posted on
2024-03-26
Participant Flow
Participant milestones
| Measure |
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Tecartus
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 2: Itacitinib 200 mg BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
|
Part 2: Placebo BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
|
|---|---|---|---|---|---|
|
Part 1: Open-label (29 Days)
STARTED
|
16
|
12
|
35
|
0
|
0
|
|
Part 1: Open-label (29 Days)
COMPLETED
|
11
|
10
|
22
|
0
|
0
|
|
Part 1: Open-label (29 Days)
NOT COMPLETED
|
5
|
2
|
13
|
0
|
0
|
|
Part 2: Randomized (29 Days)
STARTED
|
0
|
0
|
0
|
23
|
24
|
|
Part 2: Randomized (29 Days)
COMPLETED
|
0
|
0
|
0
|
17
|
15
|
|
Part 2: Randomized (29 Days)
NOT COMPLETED
|
0
|
0
|
0
|
6
|
9
|
Reasons for withdrawal
| Measure |
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Tecartus
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 2: Itacitinib 200 mg BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
|
Part 2: Placebo BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
|
|---|---|---|---|---|---|
|
Part 1: Open-label (29 Days)
Death
|
4
|
2
|
8
|
0
|
0
|
|
Part 1: Open-label (29 Days)
Progressive Disease
|
0
|
0
|
4
|
0
|
0
|
|
Part 1: Open-label (29 Days)
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
0
|
|
Part 2: Randomized (29 Days)
Death
|
0
|
0
|
0
|
2
|
2
|
|
Part 2: Randomized (29 Days)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
Part 2: Randomized (29 Days)
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
|
Part 2: Randomized (29 Days)
Progressive Disease
|
0
|
0
|
0
|
2
|
4
|
|
Part 2: Randomized (29 Days)
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
|
Part 2: Randomized (29 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
|
Part 2: Randomized (29 Days)
Declined Further Treatment; Entered Hospice
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
Baseline characteristics by cohort
| Measure |
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
n=16 Participants
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Tecartus
n=12 Participants
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Yescarta
n=35 Participants
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 2: Itacitinib 200 mg BID + Yescarta
n=23 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
|
Part 2: Placebo BID + Yescarta
n=24 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
68.8 years
STANDARD_DEVIATION 15.22 • n=39 Participants
|
66.2 years
STANDARD_DEVIATION 12.08 • n=41 Participants
|
63.5 years
STANDARD_DEVIATION 10.21 • n=35 Participants
|
63.2 years
STANDARD_DEVIATION 13.37 • n=31 Participants
|
62.0 years
STANDARD_DEVIATION 9.93 • n=146 Participants
|
64.18 years
STANDARD_DEVIATION 11.87 • n=19 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
7 Participants
n=146 Participants
|
32 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
15 Participants
n=31 Participants
|
17 Participants
n=146 Participants
|
78 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
4 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
32 Participants
n=35 Participants
|
20 Participants
n=31 Participants
|
23 Participants
n=146 Participants
|
100 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
6 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
13 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
21 Participants
n=31 Participants
|
21 Participants
n=146 Participants
|
98 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
3 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
4 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
American-Indian/Alaska Native
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
Captured as "Other" in Database
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
4 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: up to Day 14 of Parts 1 and 2Population: Efficacy Evaluable Analysis Set (EAS): all participants who received at least 1 dose of study drug and received IEC therapy. The exact 95% confidence interval (2-sided) was calculated using the Clopper-Pearson method.
The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 2 CRS: temperature ≥38°C not attributable to any other cause, defined as fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressin, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at \>6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., continuous positive airway pressure \[CPAP\], bilevel intermittent positive air pressure \[BiPAP\], intubation, mechanical ventilation).
Outcome measures
| Measure |
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
n=16 Participants
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Tecartus
n=12 Participants
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Yescarta
n=35 Participants
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 2: Itacitinib 200 mg BID + Yescarta
n=23 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
|
Part 2: Placebo BID + Yescarta
n=23 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Developed ≥Grade 2 Cytokine Release Syndrome (CRS) by Day 14 After Immune Effector Cell (IEC) Therapy, Assessed by Using American Society for Blood and Marrow Transplantation (ASBMT) CRS Consensus Grading
|
12.5 percentage of participants
Interval 1.6 to 38.3
|
41.7 percentage of participants
Interval 15.2 to 72.3
|
20.0 percentage of participants
Interval 8.4 to 36.9
|
17.4 percentage of participants
Interval 5.0 to 38.8
|
56.5 percentage of participants
Interval 34.5 to 76.8
|
SECONDARY outcome
Timeframe: up to Day 28 of Parts 1 and 2Population: EAS. The exact 95% confidence interval (2-sided) was calculated using the Clopper-Pearson method.
Participants were monitored for signs and symptoms of ICANS, if symptoms developed at any point after IEC. ICANS Consensus Grading Criteria were used to assess 5 domains of neurotoxicity: orientation (orient to year, month, city, and hospital), naming (naming 3 objects), following commands (follow commands such as: show me 2 fingers or close your eyes and stick out your tongue), writing (ability to write a standard sentence), and attention (count backwards from 100 by 10). Each domain is associated with a certain number of points, which are summed to generate a total score. Score 10: no impairment; score 7-9: Grade 1 ICANS; score 3-6: Grade 2 ICANS; score 0-2: Grade 3 ICANS.
Outcome measures
| Measure |
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
n=16 Participants
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Tecartus
n=12 Participants
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Yescarta
n=35 Participants
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 2: Itacitinib 200 mg BID + Yescarta
n=23 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
|
Part 2: Placebo BID + Yescarta
n=23 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) by Day 28 After IEC Therapy, Assessed by Using the ICANS Consensus Grading
|
31.3 percentage of participants
Interval 11.0 to 58.7
|
41.7 percentage of participants
Interval 15.2 to 72.3
|
45.7 percentage of participants
Interval 28.8 to 63.4
|
13.0 percentage of participants
Interval 2.8 to 33.6
|
34.8 percentage of participants
Interval 16.4 to 57.3
|
SECONDARY outcome
Timeframe: up to Day 28 of Parts 1 and 2Population: EAS. Only participants with ICANS onset by Day 28 were analyzed.
Participants were monitored for signs and symptoms of ICANS, if symptoms developed at any point after IEC. ICANS Consensus Grading Criteria were used to assess 5 domains of neurotoxicity: orientation (orient to year, month, city, and hospital), naming (naming 3 objects), following commands (follow commands such as: show me 2 fingers or close your eyes and stick out your tongue), writing (ability to write a standard sentence), and attention (count backwards from 100 by 10). Each domain is associated with a certain number of points, which are summed to generate a total score. Score 10: no impairment; score 7-9: Grade 1 ICANS; score 3-6: Grade 2 ICANS; score 0-2: Grade 3 ICANS.
Outcome measures
| Measure |
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
n=5 Participants
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Tecartus
n=5 Participants
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Yescarta
n=16 Participants
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 2: Itacitinib 200 mg BID + Yescarta
n=3 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
|
Part 2: Placebo BID + Yescarta
n=8 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
|
|---|---|---|---|---|---|
|
Time to Onset of ICANS Using the ICANS Consensus Grading, Regardless of CRS, by Day 28 After IEC Therapy
|
4.0 days
Interval 0.0 to 11.0
|
4.0 days
Interval 0.0 to 6.0
|
5.0 days
Interval 1.0 to 9.0
|
5.0 days
Interval 4.0 to 9.0
|
6.5 days
Interval 2.0 to 11.0
|
SECONDARY outcome
Timeframe: up to Day 28 of Parts 1 and 2Population: EAS. Only participants with ICANS onset by Day 28 were analyzed.
Participants were monitored for signs and symptoms of ICANS, if symptoms developed at any point after IEC. ICANS Consensus Grading Criteria were used to assess 5 domains of neurotoxicity: orientation (orient to year, month, city, and hospital), naming (naming 3 objects), following commands (follow commands such as: show me 2 fingers or close your eyes and stick out your tongue), writing (ability to write a standard sentence), and attention (count backwards from 100 by 10). Each domain is associated with a certain number of points, which are summed to generate a total score. Score 10: no impairment; score 7-9: Grade 1 ICANS; score 3-6: Grade 2 ICANS; score 0-2: Grade 3 ICANS. Duration of ICANS occurring by Day 28 corresponds to the sum of days with non-zero grade ICANS by Day 28.
Outcome measures
| Measure |
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
n=5 Participants
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Tecartus
n=5 Participants
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Yescarta
n=16 Participants
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 2: Itacitinib 200 mg BID + Yescarta
n=3 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
|
Part 2: Placebo BID + Yescarta
n=8 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
|
|---|---|---|---|---|---|
|
Duration of ICANS Occurring by Day 28 After IEC Therapy Using the ICANS Consensus Grading, Regardless of CRS
|
3.0 days
Interval 1.0 to 4.0
|
5.0 days
Interval 1.0 to 17.0
|
1.5 days
Interval 1.0 to 16.0
|
2.0 days
Interval 2.0 to 11.0
|
3.5 days
Interval 2.0 to 13.0
|
SECONDARY outcome
Timeframe: up to Day 28 of Parts 1 and 2Population: EAS. Only participants with CRS onset by Day 28 were analyzed.
The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at \>6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).
Outcome measures
| Measure |
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
n=14 Participants
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Tecartus
n=10 Participants
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Yescarta
n=30 Participants
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 2: Itacitinib 200 mg BID + Yescarta
n=15 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
|
Part 2: Placebo BID + Yescarta
n=20 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
|
|---|---|---|---|---|---|
|
Time to Onset of All Grades of CRS by Day 28 After IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading
|
2.0 days
Interval 1.0 to 6.0
|
2.5 days
Interval 0.0 to 7.0
|
1.0 days
Interval 1.0 to 8.0
|
2.0 days
Interval 0.0 to 8.0
|
3.0 days
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: up to Day 56 of Parts 1 and 2Population: EAS. Only participants with CRS onset by Day 28 were analyzed.
The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at \>6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).
Outcome measures
| Measure |
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
n=14 Participants
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Tecartus
n=10 Participants
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Yescarta
n=30 Participants
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 2: Itacitinib 200 mg BID + Yescarta
n=15 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
|
Part 2: Placebo BID + Yescarta
n=20 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
|
|---|---|---|---|---|---|
|
Duration of All Grades of CRS Occurring by Day 28 After IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading
|
5.0 days
Interval 2.0 to 11.0
|
4.0 days
Interval 2.0 to 11.0
|
5.0 days
Interval 1.0 to 11.0
|
5.0 days
Interval 3.0 to 12.0
|
4.0 days
Interval 1.0 to 8.0
|
SECONDARY outcome
Timeframe: up to Day 2 of Parts 1 and 2Population: EAS. The exact 95% confidence interval (2-sided) was calculated using the Clopper-Pearson method.
The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at \>6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).
Outcome measures
| Measure |
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
n=16 Participants
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Tecartus
n=12 Participants
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Yescarta
n=35 Participants
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 2: Itacitinib 200 mg BID + Yescarta
n=23 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
|
Part 2: Placebo BID + Yescarta
n=23 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Any Grade of CRS at 48 Hours After IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading
|
37.5 percentage of participants
Interval 15.2 to 64.6
|
33.3 percentage of participants
Interval 9.9 to 65.1
|
48.6 percentage of participants
Interval 31.4 to 66.0
|
26.1 percentage of participants
Interval 10.2 to 48.4
|
30.4 percentage of participants
Interval 13.2 to 52.9
|
SECONDARY outcome
Timeframe: up to Day 28 of Parts 1 and 2Population: EAS. The exact 95% confidence interval (2-sided) was calculated using the Clopper-Pearson method.
The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at \>6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).
Outcome measures
| Measure |
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
n=16 Participants
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Tecartus
n=12 Participants
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Yescarta
n=35 Participants
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 2: Itacitinib 200 mg BID + Yescarta
n=23 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
|
Part 2: Placebo BID + Yescarta
n=23 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
|
|---|---|---|---|---|---|
|
Percentage of Participants With ≥Grade 2 CRS by Day 28 After First IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading
|
12.5 percentage of participants
Interval 1.6 to 38.3
|
41.7 percentage of participants
Interval 15.2 to 72.3
|
20.0 percentage of participants
Interval 8.4 to 36.9
|
21.7 percentage of participants
Interval 7.5 to 43.7
|
56.5 percentage of participants
Interval 34.5 to 76.8
|
SECONDARY outcome
Timeframe: from at Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2Population: Safety Evaluable Set: all enrolled participants who received at least 1 dose of study drug
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. For purposes of analysis, all AEs were considered TEAEs unless the AE could unequivocally be defined as not treatment emergent.
Outcome measures
| Measure |
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
n=16 Participants
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Tecartus
n=12 Participants
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Yescarta
n=35 Participants
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 2: Itacitinib 200 mg BID + Yescarta
n=23 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
|
Part 2: Placebo BID + Yescarta
n=24 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
|
|---|---|---|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Except CRS and ICANS
|
16 participants
|
12 participants
|
35 participants
|
22 participants
|
24 participants
|
SECONDARY outcome
Timeframe: Day 28 of Parts 1 and 2Population: EAS. Only participants with available data were analyzed.
Cytopenia is characterized by low levels of white blood cells, red blood cells, or platelets. Analysis used laboratory counts at Day 28.
Outcome measures
| Measure |
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
n=16 Participants
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Tecartus
n=12 Participants
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Yescarta
n=35 Participants
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 2: Itacitinib 200 mg BID + Yescarta
n=23 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
|
Part 2: Placebo BID + Yescarta
n=23 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Any ≥Grade 3 Cytopenias Ongoing at Day 28
Neutrophils
|
8.3 percentage of participants
|
22.2 percentage of participants
|
26.6 percentage of participants
|
31.8 percentage of participants
|
13.6 percentage of participants
|
|
Percentage of Participants With Any ≥Grade 3 Cytopenias Ongoing at Day 28
Platelets
|
25.0 percentage of participants
|
50.0 percentage of participants
|
26.7 percentage of participants
|
36.4 percentage of participants
|
18.2 percentage of participants
|
|
Percentage of Participants With Any ≥Grade 3 Cytopenias Ongoing at Day 28
Hemoglobin
|
0.0 percentage of participants
|
20.0 percentage of participants
|
16.7 percentage of participants
|
9.1 percentage of participants
|
4.5 percentage of participants
|
SECONDARY outcome
Timeframe: up to Day 56 of Parts 1 and 2Population: EAS
Tocilizumab and/or corticosteroids for CRS Grade 1 was not allowed per the protocol. However, tocilizumab may have been given as rescue medication for CRS Grade 1 if no improvement was observed within 72 hours from onset, and the participant's medical condition required intervention per investigator judgment.
Outcome measures
| Measure |
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
n=16 Participants
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Tecartus
n=12 Participants
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Yescarta
n=35 Participants
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 2: Itacitinib 200 mg BID + Yescarta
n=23 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
|
Part 2: Placebo BID + Yescarta
n=23 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Were Treated With Tocilizumab for CRS
|
18.8 percentage of participants
|
41.7 percentage of participants
|
20.0 percentage of participants
|
17.4 percentage of participants
|
65.2 percentage of participants
|
SECONDARY outcome
Timeframe: up to Day 30 of Parts 1 and 2Population: EAS
Dexamethasone use as rescue medication for ICANS was assessed.
Outcome measures
| Measure |
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
n=16 Participants
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Tecartus
n=12 Participants
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Yescarta
n=35 Participants
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 2: Itacitinib 200 mg BID + Yescarta
n=23 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
|
Part 2: Placebo BID + Yescarta
n=23 Participants
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
|
|---|---|---|---|---|---|
|
Percentage of Participants Requiring More Than 1 Dose of Dexamethasone (or Equivalent) for ICANS
|
12.5 percentage of participants
|
25.0 percentage of participants
|
22.9 percentage of participants
|
4.3 percentage of participants
|
30.4 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to Day 180 of Parts 1 and 2Population: Data have not been reported, as the outcome measure is exploratory.
The number of hospital admissions was assessed through study completion.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to Day 180 of Parts 1 and 2Population: Data have not been reported as the outcome measure is exploratory.
The duration of hospital stays was assessed through study completion.
Outcome measures
Outcome data not reported
Adverse Events
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Serious events: 2 serious events
Other events: 16 other events
Deaths: 4 deaths
Part 1: Itacitinib 200 mg QD + Tecartus
Serious events: 1 serious events
Other events: 12 other events
Deaths: 2 deaths
Part 1: Itacitinib 200 mg QD + Yescarta
Serious events: 9 serious events
Other events: 35 other events
Deaths: 9 deaths
Part 1: Itacitinib 200 mg + Any IEC
Serious events: 12 serious events
Other events: 63 other events
Deaths: 15 deaths
Part 2: Itacitinib 200 mg BID + Yescarta
Serious events: 3 serious events
Other events: 22 other events
Deaths: 2 deaths
Part 2: Placebo BID + Yescarta
Serious events: 6 serious events
Other events: 24 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
n=16 participants at risk
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Tecartus
n=12 participants at risk
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Yescarta
n=35 participants at risk
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg + Any IEC
n=63 participants at risk
Participants being treated with Kymriah, Yescarta, and Tecartus (Day 0; per prescribing information), IEC therapies for hematologic malignancies, received itacitinib 200 mg once daily for 30 days (Day -3 to Day 26).
|
Part 2: Itacitinib 200 mg BID + Yescarta
n=23 participants at risk
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
|
Part 2: Placebo BID + Yescarta
n=24 participants at risk
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
|
|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/63 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/63 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/63 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/63 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Infections and infestations
Fusarium infection
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/63 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/63 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Nervous system disorders
Immune effector cell-associated neurotoxicity syndrome
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/63 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/63 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/63 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
General disorders
Pyrexia
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
5.7%
2/35 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.8%
3/63 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Nervous system disorders
Seizure
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Infections and infestations
Sepsis
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
5.7%
2/35 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Infections and infestations
Sinusitis fungal
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/63 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/63 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Nervous system disorders
VIth nerve disorder
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/63 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
Other adverse events
| Measure |
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
n=16 participants at risk
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Tecartus
n=12 participants at risk
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg QD + Yescarta
n=35 participants at risk
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
|
Part 1: Itacitinib 200 mg + Any IEC
n=63 participants at risk
Participants being treated with Kymriah, Yescarta, and Tecartus (Day 0; per prescribing information), IEC therapies for hematologic malignancies, received itacitinib 200 mg once daily for 30 days (Day -3 to Day 26).
|
Part 2: Itacitinib 200 mg BID + Yescarta
n=23 participants at risk
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
|
Part 2: Placebo BID + Yescarta
n=24 participants at risk
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
|
|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Urinary incontinence
|
12.5%
2/16 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
5.7%
2/35 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
6.3%
4/63 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.7%
2/23 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Eye disorders
Vision blurred
|
12.5%
2/16 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
2/12 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.6%
3/35 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
11.1%
7/63 • Number of events 11 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
13.0%
3/23 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
4/24 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Investigations
Weight decreased
|
18.8%
3/16 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.8%
3/63 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
2/12 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
17.1%
6/35 • Number of events 10 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
12.7%
8/63 • Number of events 13 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
26.1%
6/23 • Number of events 12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
4/24 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
14.3%
5/35 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
9.5%
6/63 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.8%
3/63 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
5.7%
2/35 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Psychiatric disorders
Affect lability
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Psychiatric disorders
Agitation
|
6.2%
1/16 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.7%
2/23 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
20.8%
5/24 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Investigations
Amylase increased
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
2/12 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.8%
3/63 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Blood and lymphatic system disorders
Anaemia
|
43.8%
7/16 • Number of events 9 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
41.7%
5/12 • Number of events 8 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
25.7%
9/35 • Number of events 14 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
33.3%
21/63 • Number of events 31 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
21.7%
5/23 • Number of events 9 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
25.0%
6/24 • Number of events 7 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Gastrointestinal disorders
Anal incontinence
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Psychiatric disorders
Anxiety
|
12.5%
2/16 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
5.7%
2/35 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
7.9%
5/63 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Gastrointestinal disorders
Aphthous ulcer
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.8%
3/16 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.6%
3/35 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
9.5%
6/63 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
12.5%
3/24 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
2/16 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
5.7%
2/35 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
6.3%
4/63 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
13.0%
3/23 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
12.5%
3/24 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.8%
3/16 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
2/12 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.6%
3/35 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
12.7%
8/63 • Number of events 8 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.7%
2/23 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
4/24 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Investigations
Blood alkaline phosphatase increased
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
2/12 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
5.7%
2/35 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
7.9%
5/63 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
12.5%
3/24 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
25.0%
3/12 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
7.9%
5/63 • Number of events 7 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Investigations
C-reactive protein increased
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
25.0%
3/12 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
6.3%
4/63 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
General disorders
Catheter site haemorrhage
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
General disorders
Catheter site related reaction
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
General disorders
Chills
|
37.5%
6/16 • Number of events 8 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
33.3%
4/12 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
22.9%
8/35 • Number of events 8 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
28.6%
18/63 • Number of events 21 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
39.1%
9/23 • Number of events 12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
25.0%
6/24 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Infections and infestations
Chronic sinusitis
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Psychiatric disorders
Confusional state
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
2/12 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
11.4%
4/35 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
11.1%
7/63 • Number of events 7 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.7%
2/23 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Gastrointestinal disorders
Constipation
|
37.5%
6/16 • Number of events 9 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
33.3%
4/12 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
20.0%
7/35 • Number of events 7 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
27.0%
17/63 • Number of events 20 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
26.1%
6/23 • Number of events 7 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
20.8%
5/24 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
3/16 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
2/12 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
11.4%
4/35 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
14.3%
9/63 • Number of events 9 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
20.8%
5/24 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Infections and infestations
Cytomegalovirus viraemia
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
8/16 • Number of events 11 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
33.3%
4/12 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
11.4%
4/35 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
25.4%
16/63 • Number of events 19 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
21.7%
5/23 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
29.2%
7/24 • Number of events 7 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Vascular disorders
Deep vein thrombosis
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.8%
3/63 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
17.4%
4/23 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Psychiatric disorders
Delirium febrile
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
8/16 • Number of events 9 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
33.3%
4/12 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
17.1%
6/35 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
28.6%
18/63 • Number of events 19 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
21.7%
5/23 • Number of events 8 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
29.2%
7/24 • Number of events 7 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Psychiatric disorders
Disorganised speech
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Nervous system disorders
Dizziness
|
18.8%
3/16 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
2/12 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
17.1%
6/35 • Number of events 7 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
17.5%
11/63 • Number of events 12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
17.4%
4/23 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
20.8%
5/24 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.6%
3/35 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.8%
3/63 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.7%
2/23 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
5.7%
2/35 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.8%
3/63 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
17.1%
6/35 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
11.1%
7/63 • Number of events 7 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.7%
2/23 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Renal and urinary disorders
Dysuria
|
12.5%
2/16 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.8%
3/63 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Investigations
Electrocardiogram QT prolonged
|
12.5%
2/16 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
General disorders
Facial pain
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
11.4%
4/35 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
7.9%
5/63 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
General disorders
Fatigue
|
50.0%
8/16 • Number of events 9 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
50.0%
6/12 • Number of events 7 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
51.4%
18/35 • Number of events 18 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
50.8%
32/63 • Number of events 34 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
30.4%
7/23 • Number of events 8 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
41.7%
10/24 • Number of events 10 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
2/16 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
5.7%
2/35 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
7.9%
5/63 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
17.4%
4/23 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
12.5%
3/24 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Metabolism and nutrition disorders
Fluid intake reduced
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Vascular disorders
Flushing
|
12.5%
2/16 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
General disorders
Gait disturbance
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Infections and infestations
Gastroenteritis staphylococcal
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Vascular disorders
Haematoma
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Nervous system disorders
Headache
|
43.8%
7/16 • Number of events 8 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
58.3%
7/12 • Number of events 8 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
34.3%
12/35 • Number of events 14 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
41.3%
26/63 • Number of events 30 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
26.1%
6/23 • Number of events 8 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
33.3%
8/24 • Number of events 8 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Nervous system disorders
Hyperaesthesia
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
4/24 • Number of events 7 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
13.0%
3/23 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.2%
1/16 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.7%
2/23 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Immune system disorders
Hypersensitivity
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Vascular disorders
Hypertension
|
25.0%
4/16 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
7.9%
5/63 • Number of events 7 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
12.5%
3/24 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Nervous system disorders
Hypoaesthesia
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
12.5%
2/16 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
5.7%
2/35 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
7.9%
5/63 • Number of events 9 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
4/24 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.5%
2/16 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
2/12 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
5.7%
2/35 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
9.5%
6/63 • Number of events 7 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.7%
2/23 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
20.8%
5/24 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Immune system disorders
Hypogammaglobulinaemia
|
12.5%
2/16 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.8%
3/63 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
18.8%
3/16 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
25.0%
3/12 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
22.9%
8/35 • Number of events 11 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
22.2%
14/63 • Number of events 22 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
17.4%
4/23 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
4/24 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
25.0%
3/12 • Number of events 7 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.6%
3/35 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
11.1%
7/63 • Number of events 11 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
13.0%
3/23 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
18.8%
3/16 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.6%
3/35 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
11.1%
7/63 • Number of events 8 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
17.4%
4/23 • Number of events 8 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
20.8%
5/24 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.7%
2/23 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
18.8%
3/16 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
2/12 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
31.4%
11/35 • Number of events 12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
25.4%
16/63 • Number of events 23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
4/24 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Vascular disorders
Hypotension
|
18.8%
3/16 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
33.3%
4/12 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
40.0%
14/35 • Number of events 18 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
33.3%
21/63 • Number of events 25 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
34.8%
8/23 • Number of events 12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
37.5%
9/24 • Number of events 11 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
14.3%
5/35 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
11.1%
7/63 • Number of events 7 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
13.0%
3/23 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
20.8%
5/24 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
4/24 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Psychiatric disorders
Insomnia
|
18.8%
3/16 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
50.0%
6/12 • Number of events 7 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
14.3%
5/35 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
22.2%
14/63 • Number of events 15 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.7%
2/23 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
4/24 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Investigations
Lipase increased
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
25.0%
3/12 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
6.3%
4/63 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Investigations
Lymphocyte count decreased
|
12.5%
2/16 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
25.0%
3/12 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
17.1%
6/35 • Number of events 9 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
17.5%
11/63 • Number of events 17 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
34.8%
8/23 • Number of events 13 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
29.2%
7/24 • Number of events 12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.5%
2/16 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
2/12 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
6.3%
4/63 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
General disorders
Malaise
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
13.0%
3/23 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Nervous system disorders
Memory impairment
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Nervous system disorders
Mental impairment
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.6%
3/35 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.8%
3/63 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
12.5%
2/16 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
6.3%
4/63 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/63 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.7%
2/23 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
2/16 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
2/12 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
11.4%
4/35 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
12.7%
8/63 • Number of events 8 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Nervous system disorders
Myoclonus
|
12.5%
2/16 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/63 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Gastrointestinal disorders
Nausea
|
31.2%
5/16 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
41.7%
5/12 • Number of events 7 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
42.9%
15/35 • Number of events 21 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
39.7%
25/63 • Number of events 33 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
26.1%
6/23 • Number of events 9 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
41.7%
10/24 • Number of events 10 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Nervous system disorders
Neurotoxicity
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
5.7%
2/35 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
6.3%
4/63 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.8%
3/16 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
25.0%
3/12 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.6%
3/35 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
14.3%
9/63 • Number of events 14 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.7%
2/23 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Investigations
Neutrophil count decreased
|
12.5%
2/16 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
2/12 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
22.9%
8/35 • Number of events 14 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
19.0%
12/63 • Number of events 19 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
39.1%
9/23 • Number of events 19 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
29.2%
7/24 • Number of events 11 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Renal and urinary disorders
Nocturia
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
General disorders
Non-cardiac chest pain
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
General disorders
Oedema
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
General disorders
Oedema peripheral
|
31.2%
5/16 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.6%
3/35 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
12.7%
8/63 • Number of events 8 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Infections and infestations
Onychomycosis
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
2/12 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
5.7%
2/35 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
6.3%
4/63 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Gastrointestinal disorders
Oral pain
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
2/12 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Vascular disorders
Orthostatic hypotension
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.6%
3/35 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
7.9%
5/63 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.7%
2/23 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
General disorders
Pain
|
18.8%
3/16 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
5.7%
2/35 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
7.9%
5/63 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.7%
2/23 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.6%
3/35 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
6.3%
4/63 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Penile ulceration
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Investigations
Platelet count decreased
|
25.0%
4/16 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
2/12 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
17.1%
6/35 • Number of events 10 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
19.0%
12/63 • Number of events 19 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
17.4%
4/23 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
4/24 • Number of events 8 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/63 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.7%
2/23 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Infections and infestations
Polyomavirus viraemia
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Purpura
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
General disorders
Pyrexia
|
50.0%
8/16 • Number of events 13 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
66.7%
8/12 • Number of events 12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
62.9%
22/35 • Number of events 25 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
60.3%
38/63 • Number of events 50 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
43.5%
10/23 • Number of events 13 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
50.0%
12/24 • Number of events 14 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.8%
3/63 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.2%
1/24 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
2/12 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.5%
2/16 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
6.3%
4/63 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Immune system disorders
Seasonal allergy
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Infections and infestations
Sepsis
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/63 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Investigations
Serum ferritin increased
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
2.9%
1/35 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Cardiac disorders
Sinus bradycardia
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
5.7%
2/35 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.8%
3/63 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
4.3%
1/23 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
16.7%
2/12 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
14.3%
5/35 • Number of events 6 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
11.1%
7/63 • Number of events 8 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
13.0%
3/23 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
12.5%
3/24 • Number of events 4 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Infections and infestations
Staphylococcal infection
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Gastrointestinal disorders
Stomatitis
|
6.2%
1/16 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/35 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
1.6%
1/63 • Number of events 1 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/23 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
5.7%
2/35 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
3.2%
2/63 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.7%
2/23 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Cardiac disorders
Tachycardia
|
12.5%
2/16 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
1/12 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
14.3%
5/35 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
12.7%
8/63 • Number of events 9 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.7%
2/23 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.3%
2/24 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
2/16 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
25.0%
3/12 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
5.7%
2/35 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
11.1%
7/63 • Number of events 9 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
8.7%
2/23 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/24 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
|
Nervous system disorders
Tremor
|
12.5%
2/16 • Number of events 2 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
0.00%
0/12 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
14.3%
5/35 • Number of events 5 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
11.1%
7/63 • Number of events 7 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
13.0%
3/23 • Number of events 3 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
29.2%
7/24 • Number of events 8 • TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER