Trial Outcomes & Findings for Phase 1 Study of Shattuck Labs (SL)-172154 in Subjects With MDS or AML (NCT NCT05275439)
NCT ID: NCT05275439
Last Updated: 2026-03-18
Results Overview
Number of participants with treatment emergent adverse events from dose escalation and dose expansion cohorts
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
106 participants
Primary outcome timeframe
From Day 1 to study completion, an average of 2-5 months depending on the treatment arm
Results posted on
2026-03-18
Participant Flow
Participant milestones
| Measure |
Dose Escalation: 1.0 mg/kg SL-172154 Monotherapy
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 3.0 mg/kg SL-172154 Monotherapy
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 6.0 mg/kg SL-172154 Monotherapy
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 1.0 mg/kg SL-172154 + Azacitidine
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 3.0 mg/kg SL-172154 + Azacitidine
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 6.0 mg/kg SL-172154 + Azacitidine
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part A (HR-MDS): SL-172154 + Azacitidine
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part C (TP53m AML): SL-172154 + Azacitidine
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Part D-Previously Untreated HR-MDS (3 mg/kg SL-172154 + AZA)
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Part D-Previously Untreated HR-MDS (1 mg/kg SL-172154 + AZA)
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Part D-Previously Untreated HR-MDS (AZA Monotherapy)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
8
|
7
|
8
|
9
|
1
|
23
|
21
|
9
|
8
|
8
|
|
Overall Study
COMPLETED
|
4
|
8
|
7
|
8
|
9
|
1
|
23
|
21
|
9
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1 Study of Shattuck Labs (SL)-172154 in Subjects With MDS or AML
Baseline characteristics by cohort
| Measure |
Dose Escalation: 1.0 mg/kg SL-172154 Monotherapy
n=4 Participants
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 3.0 mg/kg SL-172154 Monotherapy
n=8 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 6.0 mg/kg SL-172154 Monotherapy
n=7 Participants
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 1.0 mg/kg SL-172154 + Azacitidine
n=8 Participants
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 3.0 mg/kg SL-172154 + Azacitidine
n=9 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 6.0 mg/kg SL-172154 + Azacitidine
n=1 Participants
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part A (HR-MDS): SL-172154 + Azacitidine
n=23 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part C (TP53m AML): SL-172154 + Azacitidine
n=21 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Part D-Previously Untreated HR-MDS (3 mg/kg SL-172154 + AZA)
n=9 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Part D-Previously Untreated HR-MDS (1 mg/kg SL-172154 + AZA)
n=8 Participants
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Part D-Previously Untreated HR-MDS (AZA Monotherapy)
n=8 Participants
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.0 years
n=110 Participants
|
72.0 years
n=114 Participants
|
66.0 years
n=224 Participants
|
70.0 years
n=104 Participants
|
68.0 years
n=2 Participants
|
74.0 years
n=2 Participants
|
74.0 years
n=14 Participants
|
74.0 years
n=52 Participants
|
71.0 years
n=629 Participants
|
68.0 years
n=3 Participants
|
69.0 years
n=3 Participants
|
72.0 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=110 Participants
|
4 Participants
n=114 Participants
|
5 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
8 Participants
n=14 Participants
|
6 Participants
n=52 Participants
|
2 Participants
n=629 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
34 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=110 Participants
|
4 Participants
n=114 Participants
|
2 Participants
n=224 Participants
|
8 Participants
n=104 Participants
|
7 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
15 Participants
n=14 Participants
|
15 Participants
n=52 Participants
|
7 Participants
n=629 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=3 Participants
|
72 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
1 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=52 Participants
|
2 Participants
n=629 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=110 Participants
|
8 Participants
n=114 Participants
|
6 Participants
n=224 Participants
|
7 Participants
n=104 Participants
|
9 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
23 Participants
n=14 Participants
|
20 Participants
n=52 Participants
|
7 Participants
n=629 Participants
|
8 Participants
n=3 Participants
|
8 Participants
n=3 Participants
|
99 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=629 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=629 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=52 Participants
|
1 Participants
n=629 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=629 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=14 Participants
|
1 Participants
n=52 Participants
|
2 Participants
n=629 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=110 Participants
|
8 Participants
n=114 Participants
|
6 Participants
n=224 Participants
|
8 Participants
n=104 Participants
|
7 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
21 Participants
n=14 Participants
|
19 Participants
n=52 Participants
|
5 Participants
n=629 Participants
|
8 Participants
n=3 Participants
|
8 Participants
n=3 Participants
|
95 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=629 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=52 Participants
|
1 Participants
n=629 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=110 Participants
|
0 participants
n=114 Participants
|
0 participants
n=224 Participants
|
0 participants
n=104 Participants
|
1 participants
n=2 Participants
|
0 participants
n=2 Participants
|
2 participants
n=14 Participants
|
0 participants
n=52 Participants
|
0 participants
n=629 Participants
|
0 participants
n=3 Participants
|
1 participants
n=3 Participants
|
4 participants
n=8 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=110 Participants
|
8 participants
n=114 Participants
|
7 participants
n=224 Participants
|
8 participants
n=104 Participants
|
8 participants
n=2 Participants
|
1 participants
n=2 Participants
|
20 participants
n=14 Participants
|
19 participants
n=52 Participants
|
9 participants
n=629 Participants
|
8 participants
n=3 Participants
|
7 participants
n=3 Participants
|
99 participants
n=8 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=110 Participants
|
0 participants
n=114 Participants
|
0 participants
n=224 Participants
|
0 participants
n=104 Participants
|
0 participants
n=2 Participants
|
0 participants
n=2 Participants
|
1 participants
n=14 Participants
|
2 participants
n=52 Participants
|
0 participants
n=629 Participants
|
0 participants
n=3 Participants
|
0 participants
n=3 Participants
|
3 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to study completion, an average of 2-5 months depending on the treatment armPopulation: Subjects who received at least one dose of study drug
Number of participants with treatment emergent adverse events from dose escalation and dose expansion cohorts
Outcome measures
| Measure |
Dose Escalation: 1.0 mg/kg SL-172154 Monotherapy
n=4 Participants
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 3.0 mg/kg SL-172154 Monotherapy
n=8 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 6.0 mg/kg SL-172154 Monotherapy
n=7 Participants
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 1.0 mg/kg SL-172154 + Azacitidine
n=8 Participants
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 3.0 mg/kg SL-172154 + Azacitidine
n=9 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 6.0 mg/kg SL-172154 + Azacitidine
n=1 Participants
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part A (HR-MDS): SL-172154 + Azacitidine
n=23 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part C (TP53m AML): SL-172154 + Azacitidine
n=21 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 6.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
AML Subjects only
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 1.0 mg/kg SL-172154 + AZA (Dose Escalation)
Relapsed/Refractory AML Subjects only
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 + AZA (Dose Escalation)
Relapsed/Refractory AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML Previously Untreated TP53m: SL-172154 + AZA (Dose Expansion)
Previously Untreated TP53m AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Expansion)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety Profile of SL-172154 Monotherapy or in Combination With Azacitidine
|
4 Participants
|
8 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
1 Participants
|
23 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to study completion, an average of 2-5 months depending on the treatment armPopulation: DLT evaluable population (Dose Escalation only)
Based on review of all data, including safety, tolerability, PK, antitumor activity, and PD effects
Outcome measures
| Measure |
Dose Escalation: 1.0 mg/kg SL-172154 Monotherapy
n=18 Participants
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 3.0 mg/kg SL-172154 Monotherapy
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 6.0 mg/kg SL-172154 Monotherapy
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 1.0 mg/kg SL-172154 + Azacitidine
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 3.0 mg/kg SL-172154 + Azacitidine
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 6.0 mg/kg SL-172154 + Azacitidine
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part A (HR-MDS): SL-172154 + Azacitidine
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part C (TP53m AML): SL-172154 + Azacitidine
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 6.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
AML Subjects only
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 1.0 mg/kg SL-172154 + AZA (Dose Escalation)
Relapsed/Refractory AML Subjects only
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 + AZA (Dose Escalation)
Relapsed/Refractory AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML Previously Untreated TP53m: SL-172154 + AZA (Dose Expansion)
Previously Untreated TP53m AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Expansion)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Recommended Phase 2 Dose of SL-172154 Administered With Azacitidine
|
3.0 mg/kg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to study completion, an average of 2-5 months depending on the treatment armPopulation: Subjects who received at least one dose of study drug
Number of participants with treatment emergent adverse events from Part D cohorts
Outcome measures
| Measure |
Dose Escalation: 1.0 mg/kg SL-172154 Monotherapy
n=9 Participants
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 3.0 mg/kg SL-172154 Monotherapy
n=7 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 6.0 mg/kg SL-172154 Monotherapy
n=8 Participants
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 1.0 mg/kg SL-172154 + Azacitidine
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 3.0 mg/kg SL-172154 + Azacitidine
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 6.0 mg/kg SL-172154 + Azacitidine
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part A (HR-MDS): SL-172154 + Azacitidine
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part C (TP53m AML): SL-172154 + Azacitidine
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 6.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
AML Subjects only
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 1.0 mg/kg SL-172154 + AZA (Dose Escalation)
Relapsed/Refractory AML Subjects only
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 + AZA (Dose Escalation)
Relapsed/Refractory AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML Previously Untreated TP53m: SL-172154 + AZA (Dose Expansion)
Previously Untreated TP53m AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Expansion)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety Profile of SL-172154 in Combination With Azacitidine or Azacitidine Monotherapy
|
9 Participants
|
7 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 24 monthsPopulation: Only MDS patients were evaluated for MDS outcomes and only AML patients were evaluated for AML outcomes.
International Working Group (IWG) 2006 criteria (MDS): Response for subjects with MDS will be evaluated based on guidelines by the IWG 2006 MDS response criteria \[Cheson, 2006\]. Subject's response is based on the most recent bone marrow results and recent hematology values. Hematology values for up to 2 weeks from the bone marrow evaluation can be used to determine the IWG response. European LeukemiaNet (ELN) 2017 criteria (AML): Response will be evaluated based on guidelines by the 2017 ELN Response Criteria in AML \[Dohner, 2017\]. Subject's response is based on the most recent bone marrow results and recent hematology values. Hematology values for up to 2 weeks from the bone marrow evaluation can be used to determine the response.
Outcome measures
| Measure |
Dose Escalation: 1.0 mg/kg SL-172154 Monotherapy
n=1 Participants
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 3.0 mg/kg SL-172154 Monotherapy
n=3 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 6.0 mg/kg SL-172154 Monotherapy
n=1 Participants
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 1.0 mg/kg SL-172154 + Azacitidine
n=3 Participants
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 3.0 mg/kg SL-172154 + Azacitidine
n=1 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 6.0 mg/kg SL-172154 + Azacitidine
n=1 Participants
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part A (HR-MDS): SL-172154 + Azacitidine
n=23 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part C (TP53m AML): SL-172154 + Azacitidine
n=3 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
n=5 Participants
AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 6.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
n=6 Participants
AML Subjects only
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 1.0 mg/kg SL-172154 + AZA (Dose Escalation)
n=5 Participants
Relapsed/Refractory AML Subjects only
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 + AZA (Dose Escalation)
n=8 Participants
Relapsed/Refractory AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML Previously Untreated TP53m: SL-172154 + AZA (Dose Expansion)
n=21 Participants
Previously Untreated TP53m AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Expansion)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Preliminary Evidence of Anti-tumor Activity of SL-172154 Administered Alone or With Azacitidine
Complete Response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
|
Preliminary Evidence of Anti-tumor Activity of SL-172154 Administered Alone or With Azacitidine
CR with incomplete hematologic recovery (AML only)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Preliminary Evidence of Anti-tumor Activity of SL-172154 Administered Alone or With Azacitidine
Morphologic leukemia-free state (AML only)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Preliminary Evidence of Anti-tumor Activity of SL-172154 Administered Alone or With Azacitidine
Partial Response (PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Preliminary Evidence of Anti-tumor Activity of SL-172154 Administered Alone or With Azacitidine
Marrow CR (HR-MDS only)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Preliminary Evidence of Anti-tumor Activity of SL-172154 Administered Alone or With Azacitidine
Stable Disease
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
8 Participants
|
|
Preliminary Evidence of Anti-tumor Activity of SL-172154 Administered Alone or With Azacitidine
Progressive Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Preliminary Evidence of Anti-tumor Activity of SL-172154 Administered Alone or With Azacitidine
Not Evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Approximately 24 monthsPopulation: Participants in Part D were not assessed for this endpoint as the trial was stopped and development was discontinued. Data collection for this endpoint stopped prior to the pre-specified necessary time points for participants in Part D.
Number of participants with positive anti-drug antibody (ADA) titer, of those who were ADA negative at baseline
Outcome measures
| Measure |
Dose Escalation: 1.0 mg/kg SL-172154 Monotherapy
n=4 Participants
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 3.0 mg/kg SL-172154 Monotherapy
n=8 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 6.0 mg/kg SL-172154 Monotherapy
n=7 Participants
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 1.0 mg/kg SL-172154 + Azacitidine
n=8 Participants
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 3.0 mg/kg SL-172154 + Azacitidine
n=9 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 6.0 mg/kg SL-172154 + Azacitidine
n=1 Participants
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part A (HR-MDS): SL-172154 + Azacitidine
n=19 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part C (TP53m AML): SL-172154 + Azacitidine
n=17 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 6.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
AML Subjects only
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 1.0 mg/kg SL-172154 + AZA (Dose Escalation)
Relapsed/Refractory AML Subjects only
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 + AZA (Dose Escalation)
Relapsed/Refractory AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML Previously Untreated TP53m: SL-172154 + AZA (Dose Expansion)
Previously Untreated TP53m AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Expansion)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity to SL-172154 During and After Treatment of SL-172154 Alone or With Azacitidine
|
0 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1/2, Cycle 1 Day 15/16, and Cycle 2 Day 1/2 (cycle = 28 days)Population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were not available for analysis. Participants in Part D were not assessed for this endpoint as the trial was stopped and development was discontinued. The study terminated prior to data analysis of samples collected from participants in Part D for this measure.
The Cmax is the maximum observed serum concentration of SL-172154 following single and multiple doses
Outcome measures
| Measure |
Dose Escalation: 1.0 mg/kg SL-172154 Monotherapy
n=4 Participants
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 3.0 mg/kg SL-172154 Monotherapy
n=8 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 6.0 mg/kg SL-172154 Monotherapy
n=7 Participants
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 1.0 mg/kg SL-172154 + Azacitidine
n=7 Participants
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 3.0 mg/kg SL-172154 + Azacitidine
n=9 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 6.0 mg/kg SL-172154 + Azacitidine
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part A (HR-MDS): SL-172154 + Azacitidine
n=22 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part C (TP53m AML): SL-172154 + Azacitidine
n=20 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 6.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
AML Subjects only
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 1.0 mg/kg SL-172154 + AZA (Dose Escalation)
Relapsed/Refractory AML Subjects only
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 + AZA (Dose Escalation)
Relapsed/Refractory AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML Previously Untreated TP53m: SL-172154 + AZA (Dose Expansion)
Previously Untreated TP53m AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Expansion)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of SL-172154
Cycle 2 Day 1 (monotherapy) or 2 (combination)
|
352.30 ng/mL
Geometric Coefficient of Variation 38.42
|
1002.63 ng/mL
Geometric Coefficient of Variation 111.22
|
1548.57 ng/mL
Geometric Coefficient of Variation 434.94
|
259.66 ng/mL
Geometric Coefficient of Variation 197.80
|
1388.22 ng/mL
Geometric Coefficient of Variation 123.20
|
—
|
1343.00 ng/mL
Geometric Coefficient of Variation 135.34
|
2814.05 ng/mL
Geometric Coefficient of Variation 168.91
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of SL-172154
Cycle 1 Day 15 (monotherapy) or 16 (combination)
|
504.32 ng/mL
Geometric Coefficient of Variation 90.89
|
3237.37 ng/mL
Geometric Coefficient of Variation 163.04
|
3114.29 ng/mL
Geometric Coefficient of Variation 261.92
|
547.65 ng/mL
Geometric Coefficient of Variation 121.71
|
1552.43 ng/mL
Geometric Coefficient of Variation 99.50
|
—
|
1379.04 ng/mL
Geometric Coefficient of Variation 124.71
|
2337.31 ng/mL
Geometric Coefficient of Variation 96.43
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of SL-172154
Cycle 1 Day 1 (monotherapy) or 2 (combination)
|
1315.05 ng/mL
Geometric Coefficient of Variation 743.22
|
2113.13 ng/mL
Geometric Coefficient of Variation 197.39
|
3699.36 ng/mL
Geometric Coefficient of Variation 432.11
|
457.97 ng/mL
Geometric Coefficient of Variation 108.28
|
1024.40 ng/mL
Geometric Coefficient of Variation 133.51
|
—
|
1362.85 ng/mL
Geometric Coefficient of Variation 133.42
|
1550.79 ng/mL
Geometric Coefficient of Variation 46.85
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1/2, Cycle 1 Day 15/16, and Cycle 2 Day 1/2 (cycle = 28 days)Population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were not available for analysis. Participants in Part D were not assessed for this endpoint as the trial was stopped and development was discontinued. The study terminated prior to data analysis of samples collected from participants in Part D for this measure.
The Tmax is the time at which the maximum concentration of SL-172154 is observed following single and multiple doses
Outcome measures
| Measure |
Dose Escalation: 1.0 mg/kg SL-172154 Monotherapy
n=4 Participants
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 3.0 mg/kg SL-172154 Monotherapy
n=8 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 6.0 mg/kg SL-172154 Monotherapy
n=7 Participants
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 1.0 mg/kg SL-172154 + Azacitidine
n=7 Participants
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 3.0 mg/kg SL-172154 + Azacitidine
n=9 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 6.0 mg/kg SL-172154 + Azacitidine
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part A (HR-MDS): SL-172154 + Azacitidine
n=22 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part C (TP53m AML): SL-172154 + Azacitidine
n=20 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 6.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
AML Subjects only
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 1.0 mg/kg SL-172154 + AZA (Dose Escalation)
Relapsed/Refractory AML Subjects only
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 + AZA (Dose Escalation)
Relapsed/Refractory AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML Previously Untreated TP53m: SL-172154 + AZA (Dose Expansion)
Previously Untreated TP53m AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Expansion)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time at Which Maximum Concentration of SL-172154 is Observed (Tmax)
Cycle 1 Day 1 (monotherapy) or 2 (combination)
|
1.13 hours
Interval 1.1 to 1.3
|
2.05 hours
Interval 2.0 to 2.1
|
3.18 hours
Interval 3.0 to 4.3
|
1.14 hours
Interval 1.0 to 1.3
|
2.08 hours
Interval 1.9 to 3.4
|
—
|
3.09 hours
Interval 2.0 to 3.5
|
3.13 hours
Interval 2.8 to 3.4
|
—
|
—
|
—
|
—
|
—
|
|
Time at Which Maximum Concentration of SL-172154 is Observed (Tmax)
Cycle 1 Day 15 (monotherapy) or 16 (combination)
|
1.10 hours
Interval 1.0 to 1.2
|
2.10 hours
Interval 2.0 to 2.1
|
3.06 hours
Interval 2.1 to 3.4
|
1.10 hours
Interval 1.1 to 2.1
|
2.08 hours
Interval 1.9 to 4.1
|
—
|
3.07 hours
Interval 2.2 to 6.1
|
3.05 hours
Interval 1.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
|
Time at Which Maximum Concentration of SL-172154 is Observed (Tmax)
Cycle 2 Day 1 (monotherapy) or 2 (combination)
|
1.06 hours
Interval 1.05 to 1.07
|
2.25 hours
Interval 2.0 to 4.6
|
3.51 hours
Interval 3.0 to 3.7
|
1.12 hours
Interval 1.1 to 2.0
|
2.28 hours
Interval 2.1 to 4.3
|
—
|
3.05 hours
Interval 2.1 to 4.5
|
3.04 hours
Interval 2.8 to 4.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, Cycle 1 Day 15/16, and Cycle 2 Day 1 (cycle = 28 days)Population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were not available for analysis. Participants in Part D were not assessed for this endpoint as the trial was stopped and development was discontinued. The study terminated prior to data analysis of samples collected from participants in Part D for this measure.
The AUC is the area under the serum concentration time curve following single and multiple doses of SL-172154
Outcome measures
| Measure |
Dose Escalation: 1.0 mg/kg SL-172154 Monotherapy
n=4 Participants
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 3.0 mg/kg SL-172154 Monotherapy
n=8 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 6.0 mg/kg SL-172154 Monotherapy
n=7 Participants
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 1.0 mg/kg SL-172154 + Azacitidine
n=7 Participants
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 3.0 mg/kg SL-172154 + Azacitidine
n=9 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 6.0 mg/kg SL-172154 + Azacitidine
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part A (HR-MDS): SL-172154 + Azacitidine
n=22 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part C (TP53m AML): SL-172154 + Azacitidine
n=20 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 6.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
AML Subjects only
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 1.0 mg/kg SL-172154 + AZA (Dose Escalation)
Relapsed/Refractory AML Subjects only
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 + AZA (Dose Escalation)
Relapsed/Refractory AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML Previously Untreated TP53m: SL-172154 + AZA (Dose Expansion)
Previously Untreated TP53m AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Expansion)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve (AUC)
Cycle 1 Day 1 (monotherapy) or 2 (combination)
|
1125.05 hours*ng/mL
Geometric Coefficient of Variation 518.12
|
2856.19 hours*ng/mL
Geometric Coefficient of Variation 196.69
|
8271.67 hours*ng/mL
Geometric Coefficient of Variation 353.84
|
400.55 hours*ng/mL
Geometric Coefficient of Variation 84.50
|
1666.04 hours*ng/mL
Geometric Coefficient of Variation 82.40
|
—
|
3122.50 hours*ng/mL
Geometric Coefficient of Variation 102.01
|
3182.84 hours*ng/mL
Geometric Coefficient of Variation 41.92
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-time Curve (AUC)
Cycle 1 Day 15 (monotherapy) or 16 (combination)
|
—
|
4887.99 hours*ng/mL
Geometric Coefficient of Variation 155.50
|
10251.48 hours*ng/mL
Geometric Coefficient of Variation 88.80
|
—
|
2601.78 hours*ng/mL
Geometric Coefficient of Variation 83.87
|
—
|
2989.98 hours*ng/mL
Geometric Coefficient of Variation 127.30
|
5834.07 hours*ng/mL
Geometric Coefficient of Variation 61.12
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-time Curve (AUC)
Cycle 2 Day 1 (monotherapy) or 2 (combination)
|
—
|
2333.66 hours*ng/mL
Geometric Coefficient of Variation 10.22
|
3570.87 hours*ng/mL
Geometric Coefficient of Variation 400.58
|
512.44 hours*ng/mL
Geometric Coefficient of Variation 34.26
|
2387.56 hours*ng/mL
Geometric Coefficient of Variation 100.71
|
—
|
2900.64 hours*ng/mL
Geometric Coefficient of Variation 117.28
|
5539.29 hours*ng/mL
Geometric Coefficient of Variation 110.49
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 24 monthsPopulation: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were not available for analysis. Participants in Part D were not assessed for this endpoint as the trial was stopped and development was discontinued. The study terminated prior to data analysis of samples collected from participants in Part D for this measure.
Terminal elimination half-life (t1/2) of SL-172154
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2 Day 1 (monotherapy) or 2 (combination) (cycle = 28 days)Population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were not available for analysis. Participants in Part D were not assessed for this endpoint as the trial was stopped and development was discontinued. The study terminated prior to data analysis of samples collected from participants in Part D for this measure.
Clearance of Sl-172154
Outcome measures
| Measure |
Dose Escalation: 1.0 mg/kg SL-172154 Monotherapy
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 3.0 mg/kg SL-172154 Monotherapy
n=2 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 6.0 mg/kg SL-172154 Monotherapy
n=4 Participants
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 1.0 mg/kg SL-172154 + Azacitidine
n=2 Participants
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 3.0 mg/kg SL-172154 + Azacitidine
n=8 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 6.0 mg/kg SL-172154 + Azacitidine
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part A (HR-MDS): SL-172154 + Azacitidine
n=13 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part C (TP53m AML): SL-172154 + Azacitidine
n=11 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 6.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
AML Subjects only
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 1.0 mg/kg SL-172154 + AZA (Dose Escalation)
Relapsed/Refractory AML Subjects only
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 + AZA (Dose Escalation)
Relapsed/Refractory AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML Previously Untreated TP53m: SL-172154 + AZA (Dose Expansion)
Previously Untreated TP53m AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Expansion)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Clearance (CL)
|
—
|
100215.35 mL/hour
Geometric Coefficient of Variation 24.60
|
112585.06 mL/hour
Geometric Coefficient of Variation 553.93
|
161851.09 mL/hour
Geometric Coefficient of Variation 8.71
|
98251.83 mL/hour
Geometric Coefficient of Variation 76.04
|
—
|
67058.61 mL/hour
Geometric Coefficient of Variation 101.63
|
48190.06 mL/hour
Geometric Coefficient of Variation 60.34
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1 (monotherapy) or 2 (combination) (cycle = 28 days)Population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were not available for analysis. Participants in Part D were not assessed for this endpoint as the trial was stopped and development was discontinued. The study terminated prior to data analysis of samples collected from participants in Part D for this measure.
Volume of distribution of SL-172154
Outcome measures
| Measure |
Dose Escalation: 1.0 mg/kg SL-172154 Monotherapy
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 3.0 mg/kg SL-172154 Monotherapy
n=2 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 6.0 mg/kg SL-172154 Monotherapy
n=4 Participants
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 1.0 mg/kg SL-172154 + Azacitidine
n=2 Participants
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 3.0 mg/kg SL-172154 + Azacitidine
n=8 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 6.0 mg/kg SL-172154 + Azacitidine
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part A (HR-MDS): SL-172154 + Azacitidine
n=13 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part C (TP53m AML): SL-172154 + Azacitidine
n=11 Participants
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 6.0 mg/kg SL-172154 Monotherapy (Dose Escalation)
AML Subjects only
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
AML: 1.0 mg/kg SL-172154 + AZA (Dose Escalation)
Relapsed/Refractory AML Subjects only
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML: 3.0 mg/kg SL-172154 + AZA (Dose Escalation)
Relapsed/Refractory AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Escalation)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
AML Previously Untreated TP53m: SL-172154 + AZA (Dose Expansion)
Previously Untreated TP53m AML Subjects only
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter (Dose Expansion)
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution
|
—
|
229628.25 mL
Geometric Coefficient of Variation 75.05
|
200581.46 mL
Geometric Coefficient of Variation 683.41
|
133477.49 mL
Geometric Coefficient of Variation 22.64
|
278692.02 mL
Geometric Coefficient of Variation 73.66
|
—
|
223116.73 mL
Geometric Coefficient of Variation 107.53
|
123635.92 mL
Geometric Coefficient of Variation 78.15
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Dose Escalation: 1.0 mg/kg SL-172154 Monotherapy
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
Dose Escalation: 3.0 mg/kg SL-172154 Monotherapy
Serious events: 6 serious events
Other events: 8 other events
Deaths: 7 deaths
Dose Escalation: 6.0 mg/kg SL-172154 Monotherapy
Serious events: 4 serious events
Other events: 7 other events
Deaths: 6 deaths
Dose Escalation: 1.0 mg/kg SL-172154 + Azacitidine
Serious events: 4 serious events
Other events: 8 other events
Deaths: 7 deaths
Dose Escalation: 3.0 mg/kg SL-172154 + Azacitidine
Serious events: 6 serious events
Other events: 9 other events
Deaths: 9 deaths
Dose Escalation: 6.0 mg/kg SL-172154 + Azacitidine
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Expansion Part A (HR-MDS): SL-172154 + Azacitidine
Serious events: 19 serious events
Other events: 23 other events
Deaths: 15 deaths
Dose Expansion Part C (TP53m AML): SL-172154 + Azacitidine
Serious events: 16 serious events
Other events: 21 other events
Deaths: 13 deaths
Part D-Previously Untreated HR-MDS (3 mg/kg SL-172154 + AZA)
Serious events: 7 serious events
Other events: 9 other events
Deaths: 2 deaths
Part D-Previously Untreated HR-MDS (1 mg/kg SL-172154 + AZA)
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Part D-Previously Untreated HR-MDS (AZA Monotherapy)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Dose Escalation: 1.0 mg/kg SL-172154 Monotherapy
n=4 participants at risk
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 3.0 mg/kg SL-172154 Monotherapy
n=8 participants at risk
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 6.0 mg/kg SL-172154 Monotherapy
n=7 participants at risk
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 1.0 mg/kg SL-172154 + Azacitidine
n=8 participants at risk
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 3.0 mg/kg SL-172154 + Azacitidine
n=9 participants at risk
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 6.0 mg/kg SL-172154 + Azacitidine
n=1 participants at risk
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part A (HR-MDS): SL-172154 + Azacitidine
n=23 participants at risk
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part C (TP53m AML): SL-172154 + Azacitidine
n=21 participants at risk
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Part D-Previously Untreated HR-MDS (3 mg/kg SL-172154 + AZA)
n=9 participants at risk
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Part D-Previously Untreated HR-MDS (1 mg/kg SL-172154 + AZA)
n=7 participants at risk
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Part D-Previously Untreated HR-MDS (AZA Monotherapy)
n=8 participants at risk
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
febrile neutropenia
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
21.7%
5/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
38.1%
8/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
33.3%
3/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
pneumonia
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
44.4%
4/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
3/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
syncope
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Cardiac disorders
cardiac arrest
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Metabolism and nutrition disorders
failure to thrive
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
fatigue
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Metabolism and nutrition disorders
hypervolaemia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Injury, poisoning and procedural complications
infusion related reaction
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
pyrexia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
respiratory syncytial virus infection
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
sepsis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
3/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Injury, poisoning and procedural complications
spinal compression fracture
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Injury, poisoning and procedural complications
subdural haematoma
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Renal and urinary disorders
acute kidney injury
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory distress syndrome
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Blood and lymphatic system disorders
anaemia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
upper respiratory tract infection
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
pneumonia respiratory syncytial viral
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
cellulitis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Immune system disorders
cytokine release syndrome
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
bronchopulmonary aspergillosis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
colitis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
soft tissue infection
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Psychiatric disorders
confusional state
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
headache
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Injury, poisoning and procedural complications
hip fracture
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Investigations
neutrophil count decreased
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
septic shock
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary emobolism
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
oedema peripheral
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Cardiac disorders
myocarditis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Vascular disorders
hypotension
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
haemorrhage intracranial
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
haematochezia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
cerebrovascular accident
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
Other adverse events
| Measure |
Dose Escalation: 1.0 mg/kg SL-172154 Monotherapy
n=4 participants at risk
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 3.0 mg/kg SL-172154 Monotherapy
n=8 participants at risk
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 6.0 mg/kg SL-172154 Monotherapy
n=7 participants at risk
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 1 and 15 of every cycle thereafter
|
Dose Escalation: 1.0 mg/kg SL-172154 + Azacitidine
n=8 participants at risk
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 3.0 mg/kg SL-172154 + Azacitidine
n=9 participants at risk
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Escalation: 6.0 mg/kg SL-172154 + Azacitidine
n=1 participants at risk
6.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part A (HR-MDS): SL-172154 + Azacitidine
n=23 participants at risk
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Dose Expansion Part C (TP53m AML): SL-172154 + Azacitidine
n=21 participants at risk
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Part D-Previously Untreated HR-MDS (3 mg/kg SL-172154 + AZA)
n=9 participants at risk
3.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Part D-Previously Untreated HR-MDS (1 mg/kg SL-172154 + AZA)
n=7 participants at risk
1.0 mg/kg SL-172154 weekly during Cycles 1 and 2; Days 2 and 16 of every cycle thereafter
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
Part D-Previously Untreated HR-MDS (AZA Monotherapy)
n=8 participants at risk
75 mg/m2 Azacitidine Days 1-7 of every cycle (or per 5-2-2 schedule)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
constipation
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
37.5%
3/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
33.3%
3/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
47.8%
11/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
52.4%
11/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
66.7%
6/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
37.5%
3/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
nausea
|
50.0%
2/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
50.0%
4/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
21.7%
5/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
57.1%
12/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
33.3%
3/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
42.9%
3/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
diarrhea
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
37.5%
3/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
21.7%
5/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
52.4%
11/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
50.0%
4/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
abdominal pain
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
13.0%
3/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
37.5%
3/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
stomatitis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
33.3%
3/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
vomiting
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
50.0%
4/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
13.0%
3/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
6/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
colitis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
mouth haemorrhage
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
oral pain
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
abdominal pain lower
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
enteritis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
epigastric discomfort
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
gingival bleeding
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
haematochezia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
haemorrhoidal haemorrhage
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
haemorrhoids
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
oral disorder
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
rectal haemorrhage
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
toothache
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
fatigue
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
33.3%
3/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
43.5%
10/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
6/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
37.5%
3/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
pyrexia
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
26.1%
6/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
42.9%
3/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
oedema peripheral
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
17.4%
4/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
33.3%
7/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
chills
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
injection site reaction
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
asthenia
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
catheter site haemorrhage
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
catheter site oedema
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
catheter site pain
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
influenza like illness
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
malaise
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
non-cardiac chest pain
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
peripheral swelling
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Blood and lymphatic system disorders
leukopenia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
26.1%
6/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
33.3%
7/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
55.6%
5/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
42.9%
3/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
42.9%
3/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
33.3%
3/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
26.1%
6/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
38.1%
8/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
33.3%
3/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Blood and lymphatic system disorders
anaemia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
3/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Blood and lymphatic system disorders
neutropenia
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
13.0%
3/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
50.0%
4/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
17.4%
4/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
6/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Investigations
platelet count decreased
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
13.0%
3/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
44.4%
4/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Investigations
neutrophil count decreased
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
21.7%
5/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
3/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
44.4%
4/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Investigations
blood bilirubin increased
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
17.4%
4/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Investigations
blood creatinine increased
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
17.4%
4/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
3/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Investigations
alanine aminotransferase increased
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
13.0%
3/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
23.8%
5/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Investigations
aspartate aminotransferase increased
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
44.4%
4/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
19.0%
4/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Investigations
blood lactate dehydrogenase increased
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Investigations
brain natriuretic peptide increased
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Investigations
fibrin D dimer increased
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Investigations
troponin increased
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Investigations
weight decreased
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
pneumonia
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
37.5%
3/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
44.4%
4/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
23.8%
5/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
57.1%
4/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
sepsis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
3/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
catheter site cellulitis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
furuncle
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
gastroenteritis viral
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
mucosal infection
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
onychomycosis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
otitis media
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
septic shock
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
sinusitis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
soft tissue infection
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Metabolism and nutrition disorders
decreased appetite
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
3/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
42.9%
3/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Metabolism and nutrition disorders
hypokalaemia
|
50.0%
2/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
21.7%
5/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
33.3%
7/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Metabolism and nutrition disorders
hypoalbuminaemia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
19.0%
4/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Metabolism and nutrition disorders
hypomagnesaemia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
37.5%
3/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Metabolism and nutrition disorders
hyponatraemia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
13.0%
3/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
3/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Metabolism and nutrition disorders
hypophosphataemia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
17.4%
4/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
19.0%
4/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Metabolism and nutrition disorders
hyperkalaemia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Metabolism and nutrition disorders
hypermagnesaemia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
21.7%
5/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
19.0%
4/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
37.5%
3/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
21.7%
5/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
23.8%
5/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary oedema
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
sinus pain
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
headache
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
50.0%
4/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
17.4%
4/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
syncope
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
dizziness
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
19.0%
4/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
brain fog
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
cerebrovascular accident
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
disturbance in attention
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
dysgeusia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
haemorrhage intracranial
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
lethargy
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
presyncope
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
sensory disturbance
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
tremor
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Skin and subcutaneous tissue disorders
erythema multiforme
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Skin and subcutaneous tissue disorders
purpura
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Skin and subcutaneous tissue disorders
dermatitis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Skin and subcutaneous tissue disorders
erythema
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Skin and subcutaneous tissue disorders
hidradenitis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
3/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Skin and subcutaneous tissue disorders
pruritis
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
3/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Injury, poisoning and procedural complications
contusion
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Injury, poisoning and procedural complications
infusion related reaction
|
50.0%
2/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
87.5%
7/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
57.1%
4/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
66.7%
6/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
43.5%
10/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
42.9%
9/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Injury, poisoning and procedural complications
skin laceration
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Injury, poisoning and procedural complications
fall
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
3/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
13.0%
3/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
23.8%
5/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
3/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Musculoskeletal and connective tissue disorders
flank pain
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Musculoskeletal and connective tissue disorders
pain in jaw
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Cardiac disorders
angina pectoris
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Cardiac disorders
atrial flutter
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Cardiac disorders
cardiac arrest
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Cardiac disorders
myocarditis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Cardiac disorders
pericardial effusion
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Cardiac disorders
sinus tachycardia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Cardiac disorders
tachycardia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
17.4%
4/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Vascular disorders
hot flush
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Vascular disorders
hypotension
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Vascular disorders
hypertension
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
13.0%
3/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Psychiatric disorders
insomnia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
13.0%
3/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
19.0%
4/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Ear and labyrinth disorders
ear pain
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Renal and urinary disorders
dysuria
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Renal and urinary disorders
pollakiuria
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Renal and urinary disorders
urinary incontinence
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Eye disorders
eye pain
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Eye disorders
ocular hyperaemia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Eye disorders
photophobia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Eye disorders
vitreous floaters
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Immune system disorders
cytokine release syndrome
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Reproductive system and breast disorders
penile swelling
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
abdominal discomfort
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
anal haemorrhage
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
dysphagia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
proctalgia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Injury, poisoning and procedural complications
procedural pain
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Injury, poisoning and procedural complications
skin abrasion
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Injury, poisoning and procedural complications
spinal compression fracture
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Injury, poisoning and procedural complications
subdural haematoma
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Blood and lymphatic system disorders
lymphocytosis
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Blood and lymphatic system disorders
spontaneous haematoma
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
injection site pain
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
gait disturbance
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
injection site haemorrhage
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Metabolism and nutrition disorders
failure to thrive
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Metabolism and nutrition disorders
hypercalcaemia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Metabolism and nutrition disorders
hyperphosphataemia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Metabolism and nutrition disorders
hypervolaemia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Metabolism and nutrition disorders
metabolic acidosis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Metabolism and nutrition disorders
tumour lysis syndrome
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Investigations
white blood cell count increased
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
19.0%
4/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
lung infiltration
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
lung opacity
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary mass
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
oral bacterial infection
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
respiratory syncytial virus infection
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
upper respiratory tract infection
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
amnesia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
cognitive disorder
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
encephalopathy
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
paraesthesia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Skin and subcutaneous tissue disorders
night sweats
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Skin and subcutaneous tissue disorders
petechiae
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Eye disorders
conjunctival haemorrhage
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Eye disorders
conjunctival oedema
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Eye disorders
visual impairment
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Eye disorders
vitreous haemorrhage
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Psychiatric disorders
confusional state
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
28.6%
2/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Psychiatric disorders
agitation
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Renal and urinary disorders
haematuria
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Renal and urinary disorders
urinary retention
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Vascular disorders
haematoma
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Vascular disorders
orthostatic hypotension
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Vascular disorders
pallor
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Reproductive system and breast disorders
vaginal discharge
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Reproductive system and breast disorders
vaginal haemorrhage
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
1/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Ear and labyrinth disorders
hypoacusis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
dry mouth
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
melaena
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Gastrointestinal disorders
mouth swelling
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
injection site erythema
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
13.0%
3/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
generalised oedema
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
General disorders
mucosal inflammation
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Injury, poisoning and procedural complications
allergic transfusion reaction
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
25.0%
2/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Injury, poisoning and procedural complications
buttock injury
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Injury, poisoning and procedural complications
hip fracture
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
cellulitis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
oral herpes
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
bronchopulmonary aspergillosis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
pneumonia respiratory syncytial viral
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
rhinitis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
rhinovirus infection
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Infections and infestations
staphylococcal bacteraemia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Blood and lymphatic system disorders
coagulopathy
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Investigations
blood alkaline phosphatase increased
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
22.2%
2/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
17.4%
4/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea exertional
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory distress syndrome
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
haemoptysis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
nasal dryness
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
pharyngeal exudate
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
pleuritic pain
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
upper airway cough syndrome
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
hypoaesthesia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Nervous system disorders
restless legs syndrome
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Skin and subcutaneous tissue disorders
skin lesion
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Skin and subcutaneous tissue disorders
urticaria
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Metabolism and nutrition disorders
hyperglycaemia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
8.7%
2/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
14.3%
3/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Metabolism and nutrition disorders
malnutrition
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Musculoskeletal and connective tissue disorders
muscular weakness
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Vascular disorders
venous thrombosis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
11.1%
1/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Cardiac disorders
bradycardia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Cardiac disorders
arrhythmia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Eye disorders
vision blurred
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.3%
1/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
9.5%
2/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Renal and urinary disorders
proteinuria
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
4.8%
1/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Renal and urinary disorders
acute kidney injury
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Renal and urinary disorders
kidney enlargement
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Hepatobiliary disorders
hyperbilirubinaemia
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Endocrine disorders
inappropriate antidiuretic hormone secretion
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
|
Product Issues
thrombosis in device
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
12.5%
1/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/23 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/21 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/9 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/7 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
0.00%
0/8 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for approximately 30 days after the last dose of study treatment, an average of 2-5 months depending on the treatment arm.
One subject in Part D (1.0 mg/kg SL-172154 + AZA) was randomized, but never dosed; therefore, this subject is not included in AE reporting.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site agrees not to publish any Study Results or data before the publication of results from the Overall Study. After Sponsor has published the results of the Overall Study, Site may publish or present results generated at Site. If Sponsor has not published results of the Overall Study within 18 months of data base lock, Site may publish the results of the Study that were generated at Site. Site agrees to first submit to Sponsor the proposed publication at least 30 days prior to the submission.
- Publication restrictions are in place
Restriction type: OTHER