Trial Outcomes & Findings for A Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease and Elevated hsCRP (NCT NCT06031844)
NCT ID: NCT06031844
Last Updated: 2026-04-09
Results Overview
Serum levels of IL-6 at 3 weeks after the start of a dosing period for DFV890. The circulating serum levels of the cytokine IL-6 were measured by a validated enzyme-linked immunosorbent assay (ELISA) assay at a qualified vendor.The Emax model selected for IL-6 analysis was a model with 2 covariates (IL-6 baseline and bodyweight) and 1 random effect.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline (before first dose of study drug), 3 weeks after the start of a dosing period for DFV890 (between Day 22 and Day 85, depending on treatment sequence assignment)
Results posted on
2026-04-09
Participant Flow
Participants were randomized in a 5:5:1:1 ratio to one of four treatment sequences
The study consisted of a screening period of up to 60 days
Participant milestones
| Measure |
Treatment Sequence 1
On Day 1, participants received 1 tablet of DFV890 matching placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 22 when they started receiving DFV890 10 mg QD. The dose of DFV890 was uptitrated to 25 mg on Day 43 and to 100 mg on Day 64.
|
Treatment Sequence 2
On Day 1, participants received 1 tablet of DFV890 matching placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 22 when they started receiving DFV890 25 mg QD. The dose of DFV890 was uptitrated to 50 mg on Day 43 and to 100 mg on Day 64.
|
Treatment Sequence 3
On Day 1, participants received 1 tablet of DFV890 10 mg QD. Participants continued receiving DFV890 10 mg QD until Day 22 when they started receiving DFV890 25 mg QD. The dose of DFV890 was uptitrated to 50 mg on Day 43 and to 100 mg on Day 64.
|
Treatment Sequence 4
On Day 1, participants received 1 tablet of DFV890 matching placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 84.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
2
|
2
|
|
Overall Study
Safety analysis set
|
10
|
10
|
2
|
2
|
|
Overall Study
PK analysis set
|
10
|
9
|
1
|
0
|
|
Overall Study
PD analysis set
|
10
|
10
|
2
|
2
|
|
Overall Study
COMPLETED
|
10
|
9
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence 1
On Day 1, participants received 1 tablet of DFV890 matching placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 22 when they started receiving DFV890 10 mg QD. The dose of DFV890 was uptitrated to 25 mg on Day 43 and to 100 mg on Day 64.
|
Treatment Sequence 2
On Day 1, participants received 1 tablet of DFV890 matching placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 22 when they started receiving DFV890 25 mg QD. The dose of DFV890 was uptitrated to 50 mg on Day 43 and to 100 mg on Day 64.
|
Treatment Sequence 3
On Day 1, participants received 1 tablet of DFV890 10 mg QD. Participants continued receiving DFV890 10 mg QD until Day 22 when they started receiving DFV890 25 mg QD. The dose of DFV890 was uptitrated to 50 mg on Day 43 and to 100 mg on Day 64.
|
Treatment Sequence 4
On Day 1, participants received 1 tablet of DFV890 matching placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 84.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
Baseline Characteristics
A Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease and Elevated hsCRP
Baseline characteristics by cohort
| Measure |
Treatment Sequence 1
n=10 Participants
On Day 1, participants received 1 tablet of DFV890 matching placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 22 when they started receiving DFV890 10 mg QD. The dose of DFV890 was uptitrated to 25 mg on Day 43 and to 100 mg on Day 64.
|
Treatment Sequence 2
n=10 Participants
On Day 1, participants received 1 tablet of DFV890 matching placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 22 when they started receiving DFV890 25 mg QD. The dose of DFV890 was uptitrated to 50 mg on Day 43 and to 100 mg on Day 64.
|
Treatment Sequence 3
n=2 Participants
On Day 1, participants received 1 tablet of DFV890 10 mg QD. Participants continued receiving DFV890 10 mg QD until Day 22 when they started receiving DFV890 25 mg QD. The dose of DFV890 was uptitrated to 50 mg on Day 43 and to 100 mg on Day 64.
|
Treatment Sequence 4
n=2 Participants
On Day 1, participants received 1 tablet of DFV890 matching placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 84.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=36 Participants
|
6 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=23 Participants
|
12 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=36 Participants
|
4 Participants
n=78 Participants
|
2 Participants
n=23 Participants
|
1 Participants
n=23 Participants
|
12 Participants
n=24 Participants
|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 7.77 • n=36 Participants
|
61.9 years
STANDARD_DEVIATION 10.63 • n=78 Participants
|
68.0 years
STANDARD_DEVIATION 4.24 • n=23 Participants
|
63.0 years
STANDARD_DEVIATION 4.24 • n=23 Participants
|
64.1 years
STANDARD_DEVIATION 8.61 • n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=36 Participants
|
2 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
2 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=36 Participants
|
8 Participants
n=78 Participants
|
2 Participants
n=23 Participants
|
2 Participants
n=23 Participants
|
22 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=36 Participants
|
1 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=36 Participants
|
9 Participants
n=78 Participants
|
2 Participants
n=23 Participants
|
2 Participants
n=23 Participants
|
23 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline (before first dose of study drug), 3 weeks after the start of a dosing period for DFV890 (between Day 22 and Day 85, depending on treatment sequence assignment)Population: Participants in the pharmacodynamic (PD) analysis set with available data for the outcome measure.
Serum levels of IL-6 at 3 weeks after the start of a dosing period for DFV890. The circulating serum levels of the cytokine IL-6 were measured by a validated enzyme-linked immunosorbent assay (ELISA) assay at a qualified vendor.The Emax model selected for IL-6 analysis was a model with 2 covariates (IL-6 baseline and bodyweight) and 1 random effect.
Outcome measures
| Measure |
DFV890 10 mg
n=10 Participants
Participants received DFV890 10 mg within the study
|
DFV890 25 mg
n=19 Participants
Participants received DFV890 25 mg within the study
|
DFV890 50 mg
n=8 Participants
Participants received DFV890 50 mg within the study
|
DFV890 100 mg
n=19 Participants
Participants received DFV890 100 mg within the study
|
Placebo
n=20 Participants
Participants received Placebo within the study
|
|---|---|---|---|---|---|
|
Ratio to Baseline Serum Levels of IL-6 for DFV890 Based on an Emax Model
|
0.7191 ratio serum levels of IL-6
Interval 0.6003 to 0.8615
|
0.5478 ratio serum levels of IL-6
Interval 0.46 to 0.6523
|
0.4512 ratio serum levels of IL-6
Interval 0.3817 to 0.5333
|
0.3901 ratio serum levels of IL-6
Interval 0.3227 to 0.4717
|
1.0828 ratio serum levels of IL-6
Interval 0.9022 to 1.2994
|
PRIMARY outcome
Timeframe: Baseline (before first dose of study drug), 3 weeks after the start of a dosing period for DFV890 (between Day 22 and Day 85, depending on treatment sequence assignment)Population: Participants in the pharmacodynamic (PD) analysis set with available data for the outcome measure.
Serum levels of IL-18 at 3 weeks after the start of a dosing period for DFV890. The circulating serum levels of the cytokine IL-18 were measured by a validated enzyme-linked immunosorbent assay (ELISA) assay at a qualified vendor.The Emax model selected for IL-18 analysis was a model with 2 covariates (IL-18 baseline and bodyweight) and 1 random effect.
Outcome measures
| Measure |
DFV890 10 mg
n=10 Participants
Participants received DFV890 10 mg within the study
|
DFV890 25 mg
n=19 Participants
Participants received DFV890 25 mg within the study
|
DFV890 50 mg
n=8 Participants
Participants received DFV890 50 mg within the study
|
DFV890 100 mg
n=19 Participants
Participants received DFV890 100 mg within the study
|
Placebo
n=20 Participants
Participants received Placebo within the study
|
|---|---|---|---|---|---|
|
Ratio to Baseline Serum Levels of IL-18 for DFV890 Based on an Emax Model
|
0.9334 ratio serum levels of IL-18
Interval 0.8876 to 0.9816
|
0.8944 ratio serum levels of IL-18
Interval 0.8513 to 0.9396
|
0.8676 ratio serum levels of IL-18
Interval 0.8269 to 0.9103
|
0.8481 ratio serum levels of IL-18
Interval 0.8055 to 0.893
|
0.9956 ratio serum levels of IL-18
Interval 0.9457 to 1.0482
|
SECONDARY outcome
Timeframe: After the last dose of each 3-week dosing period: Day 22 pre-dose, Day 43 pre-dose, Day 64 pre-dose, or Day 85, depending on treatment sequence assignmentPopulation: Participants in the pharmacokinetic (PK) analysis set with an available value after three weeks of dosing
Ctrough is the observed plasma concentration that is just prior to the beginning of, or at the end of a dosing interval.
Outcome measures
| Measure |
DFV890 10 mg
n=10 Participants
Participants received DFV890 10 mg within the study
|
DFV890 25 mg
n=19 Participants
Participants received DFV890 25 mg within the study
|
DFV890 50 mg
n=10 Participants
Participants received DFV890 50 mg within the study
|
DFV890 100 mg
n=20 Participants
Participants received DFV890 100 mg within the study
|
Placebo
Participants received Placebo within the study
|
|---|---|---|---|---|---|
|
Trough Plasma Concentration (Ctrough)
|
146 ng/mL
Standard Deviation 152
|
455 ng/mL
Standard Deviation 389
|
898 ng/mL
Standard Deviation 949
|
2050 ng/mL
Standard Deviation 1320
|
—
|
Adverse Events
DFV890 10 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DFV890 25 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DFV890 50 mg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
DFV890 100 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Sessions
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo Participants
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
DFV890 10 mg Follow-up
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
DFV890 25 mg Follow-up
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
DFV890 100 mg Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DFV890 10 mg
n=12 participants at risk
Participants received DFV890 10 mg within the study
|
DFV890 25 mg
n=21 participants at risk
Participants received DFV890 25 mg within the study
|
DFV890 50 mg
n=10 participants at risk
Participants received DFV890 50 mg within the study
|
DFV890 100 mg
n=20 participants at risk
Participants received DFV890 100 mg within the study
|
Placebo Sessions
n=28 participants at risk
Participants that received placebo in the dosing periods
|
Placebo Participants
n=22 participants at risk
Participants that received placebo within the study
|
DFV890 10 mg Follow-up
n=1 participants at risk
Participants in the follow-up phase after completing the 12-week treatment ending with DFV890 10 mg.
|
DFV890 25 mg Follow-up
n=1 participants at risk
Participants in the follow-up phase after completing the 12-week treatment ending with DFV890 25 mg.
|
DFV890 100 mg Follow-up
n=20 participants at risk
Participants in the follow-up phase after completing the 12-week treatment ending with DFV890 100 mg.
|
Placebo Follow-up
n=2 participants at risk
Participants in the follow-up phase after completing the 12-week treatment ending with placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/28 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/28 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
Other adverse events
| Measure |
DFV890 10 mg
n=12 participants at risk
Participants received DFV890 10 mg within the study
|
DFV890 25 mg
n=21 participants at risk
Participants received DFV890 25 mg within the study
|
DFV890 50 mg
n=10 participants at risk
Participants received DFV890 50 mg within the study
|
DFV890 100 mg
n=20 participants at risk
Participants received DFV890 100 mg within the study
|
Placebo Sessions
n=28 participants at risk
Participants that received placebo in the dosing periods
|
Placebo Participants
n=22 participants at risk
Participants that received placebo within the study
|
DFV890 10 mg Follow-up
n=1 participants at risk
Participants in the follow-up phase after completing the 12-week treatment ending with DFV890 10 mg.
|
DFV890 25 mg Follow-up
n=1 participants at risk
Participants in the follow-up phase after completing the 12-week treatment ending with DFV890 25 mg.
|
DFV890 100 mg Follow-up
n=20 participants at risk
Participants in the follow-up phase after completing the 12-week treatment ending with DFV890 100 mg.
|
Placebo Follow-up
n=2 participants at risk
Participants in the follow-up phase after completing the 12-week treatment ending with placebo.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
7.1%
2/28 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
9.1%
2/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/28 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
100.0%
1/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
7.1%
2/28 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
9.1%
2/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/28 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
10.0%
1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/28 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/28 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/28 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
4.8%
1/21 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/28 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
100.0%
1/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
1/12 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
4.8%
1/21 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/28 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/22 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
0.00%
0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 114 Days.
Number at risk was based on total number of unique participants for each DFV890 dose level. For placebo, since one participant could have multiple placebo dosing periods, the number at risk was defined by total number of participants in each placebo dosing period, counting multiple AEs in the same period once. Overall, 28 participants in placebo dosing periods corresponded to 22 unique participants at risk
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER