Trial Outcomes & Findings for Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure (NCT NCT02678312)
NCT ID: NCT02678312
Last Updated: 2023-02-10
Results Overview
The analyses of Cmax was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The plasma levels of sacubitril/valsartan analytes were determined using a validated LCMS/MS method with a lower limit of quantitation (LLOQ) of 1 ng/mL for sacubitril, 20 ng/mL for LBQ657, and 10 ng/mL for valsartan. The PK parameters were determined using the non-compartmental method(s).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
393 participants
Primary outcome timeframe
Age group 1: Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3: Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2
Results posted on
2023-02-10
Participant Flow
2-Part (Pt) Study: Pt 1 a single dose PK/PD study with 2 dose levels; Pt 2 is a 52-week, double blind, active controlled, randomized, safety \& efficacy study. In Pt 1, there were 3 age groups: 6 to \<18 yrs, 1 to \<6 yrs and 1 month to \<1 yr. Each received either a single low dose LCZ696 (Cohort 1), a single high dose LCZ696 (Cohort 2) or both. Cohort S included patients receiving a single low dose after having received a single high dose. The low/high doses for groups 1/2 were 0.8 \& 3.1 (mg/kg).
The low and high doses for Group 3 0.4 mg/kg and 1.6 mg/kg, respectively. 26 patients received either one or two single doses of LCZ696 in Pt 1. In Pt 2, patients were randomized to receive either LCZ696 or enalapril. 377 patients were randomized and 375 received study drug (2 did not receive drug). 11 of 26 Pt 1 patients rolled into Pt 2; however, 1 patient had two ID numbers; so only 10 unique patients were in Pt 1 \& 2.
Participant milestones
| Measure |
Part 1: Dose Cohort 1
Participants received LCZ696 0.4 mg/kg (age group 3 {1 month to \< 1 year}) or 0.8 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}), based on age, given as a single oral dose on Day 1 of period 1.
|
Part 1: Dose Cohort 2
Participants received LCZ696 1.6 mg/kg (age group 3 {1 month to \< 1 year}) or 3.1 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}), based on age, given as a single oral dose on Day 1 of period 2.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
Part 2: LCZ696
Participants received LCZ696 3.1 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}) or 2.3 mg/kg (age group 3 {1 month to \< 1 year}), based on age, orally, twice a day (BID) for 52 weeks.
|
Part 2: Enalapril
Participants received enalapril 0.2 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}) or 0.15 mg/kg (age group 3 {1 month to \< 1 year}), based on age, orally, BID, for 52 weeks.
|
|---|---|---|---|---|---|
|
Part 1 Open Label Epoch- Period 1
STARTED
|
17
|
0
|
0
|
0
|
0
|
|
Part 1 Open Label Epoch- Period 1
COMPLETED
|
14
|
0
|
0
|
0
|
0
|
|
Part 1 Open Label Epoch- Period 1
NOT COMPLETED
|
3
|
0
|
0
|
0
|
0
|
|
Part 1 Open Label Epoch- Period 2
STARTED
|
0
|
18
|
2
|
0
|
0
|
|
Part 1 Open Label Epoch- Period 2
COMPLETED
|
0
|
18
|
2
|
0
|
0
|
|
Part 1 Open Label Epoch- Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 Double Blind Epoch
STARTED
|
0
|
0
|
0
|
187
|
188
|
|
Part 2 Double Blind Epoch
COMPLETED
|
0
|
0
|
0
|
169
|
164
|
|
Part 2 Double Blind Epoch
NOT COMPLETED
|
0
|
0
|
0
|
18
|
24
|
Reasons for withdrawal
| Measure |
Part 1: Dose Cohort 1
Participants received LCZ696 0.4 mg/kg (age group 3 {1 month to \< 1 year}) or 0.8 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}), based on age, given as a single oral dose on Day 1 of period 1.
|
Part 1: Dose Cohort 2
Participants received LCZ696 1.6 mg/kg (age group 3 {1 month to \< 1 year}) or 3.1 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}), based on age, given as a single oral dose on Day 1 of period 2.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
Part 2: LCZ696
Participants received LCZ696 3.1 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}) or 2.3 mg/kg (age group 3 {1 month to \< 1 year}), based on age, orally, twice a day (BID) for 52 weeks.
|
Part 2: Enalapril
Participants received enalapril 0.2 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}) or 0.15 mg/kg (age group 3 {1 month to \< 1 year}), based on age, orally, BID, for 52 weeks.
|
|---|---|---|---|---|---|
|
Part 1 Open Label Epoch- Period 1
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
|
Part 1 Open Label Epoch- Period 1
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
Part 1 Open Label Epoch- Period 1
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
|
Part 2 Double Blind Epoch
Adverse Event
|
0
|
0
|
0
|
1
|
2
|
|
Part 2 Double Blind Epoch
Death
|
0
|
0
|
0
|
8
|
12
|
|
Part 2 Double Blind Epoch
Technical Problems
|
0
|
0
|
0
|
4
|
2
|
|
Part 2 Double Blind Epoch
Lost to Follow-up
|
0
|
0
|
0
|
0
|
2
|
|
Part 2 Double Blind Epoch
Subject/guardian Decision
|
0
|
0
|
0
|
5
|
6
|
Baseline Characteristics
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure
Baseline characteristics by cohort
| Measure |
Part 1: Dose Cohort 1
n=17 Participants
Participants received LCZ696 0.4 mg/kg (age group 3 {1 month to \< 1 year}) or 0.8 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}), based on age, given as a single oral dose on Day 1 of period 1.
|
Part 1: Dose Cohort 2
n=18 Participants
Participants received LCZ696 1.6 mg/kg (age group 3 {1 month to \< 1 year}) or 3.1 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}), based on age, given as a single oral dose on Day 1 of period 2.
|
Part 1: Dose Cohort S
n=2 Participants
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
Part 2: LCZ696
n=187 Participants
Participants received LCZ696 3.1 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}) or 2.3 mg/kg (age group 3 {1 month to \< 1 year}), based on age, orally, twice a day (BID) for 52 weeks.
|
Part 2: Enalapril
n=188 Participants
Participants received enalapril 0.2 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}) or 0.15 mg/kg (age group 3 {1 month to \< 1 year}), based on age, orally, BID, for 52 weeks.
|
Total
n=412 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
3.00 years
n=5 Participants
|
2.50 years
n=7 Participants
|
1.55 years
n=5 Participants
|
7.00 years
n=4 Participants
|
8.50 years
n=21 Participants
|
4.51 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
207 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
205 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
43 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
125 Participants
n=21 Participants
|
279 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
90 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
109 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
56 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
196 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
43 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Age group 1: Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3: Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2Population: Part 1 Pharmacokinetic (PK) Set: included all participants who completed Part 1 screening phase; who had received at least one dose of study drug during Part 1, and had at least one available, valid, PK concentration measurement (not flagged for exclusion or considered a protocol deviation from relevant PK data) during Part 1.
The analyses of Cmax was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The plasma levels of sacubitril/valsartan analytes were determined using a validated LCMS/MS method with a lower limit of quantitation (LLOQ) of 1 ng/mL for sacubitril, 20 ng/mL for LBQ657, and 10 ng/mL for valsartan. The PK parameters were determined using the non-compartmental method(s).
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=7 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
n=8 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
n=7 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
n=6 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
n=4 Participants
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
n=5 Participants
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Maximum Drug Concentration in Plasma (Cmax)
Sacubitril
|
523 nanograms per milliliter (ng/ml)
Standard Deviation 390
|
179 nanograms per milliliter (ng/ml)
Standard Deviation 97
|
1970 nanograms per milliliter (ng/ml)
Standard Deviation 1666
|
549 nanograms per milliliter (ng/ml)
Standard Deviation 298
|
124 nanograms per milliliter (ng/ml)
Standard Deviation 80
|
433 nanograms per milliliter (ng/ml)
Standard Deviation 181
|
—
|
|
Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Maximum Drug Concentration in Plasma (Cmax)
LBQ657
|
1951 nanograms per milliliter (ng/ml)
Standard Deviation 839
|
1359 nanograms per milliliter (ng/ml)
Standard Deviation 711
|
6707 nanograms per milliliter (ng/ml)
Standard Deviation 1887
|
5453 nanograms per milliliter (ng/ml)
Standard Deviation 1032
|
632 nanograms per milliliter (ng/ml)
Standard Deviation 89
|
2326 nanograms per milliliter (ng/ml)
Standard Deviation 629
|
—
|
|
Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Maximum Drug Concentration in Plasma (Cmax)
Valsartan
|
1271 nanograms per milliliter (ng/ml)
Standard Deviation 1011
|
1112 nanograms per milliliter (ng/ml)
Standard Deviation 583
|
4035 nanograms per milliliter (ng/ml)
Standard Deviation 1678
|
4935 nanograms per milliliter (ng/ml)
Standard Deviation 1268
|
440 nanograms per milliliter (ng/ml)
Standard Deviation 275
|
2487 nanograms per milliliter (ng/ml)
Standard Deviation 1564
|
—
|
PRIMARY outcome
Timeframe: Age group 1: Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3: Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2Population: Participants in the Part 1 PK Set were analyzed.
The analyses of Tmax was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The plasma levels of sacubitril/valsartan analytes were determined using a validated LCMS/MS method with a lower limit of quantitation (LLOQ) of 1 ng/mL for sacubitril, 20 ng/mL for LBQ657, and 10 ng/mL for valsartan. The PK parameters were determined using the non-compartmental method(s).
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=7 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
n=8 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
n=7 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
n=6 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
n=4 Participants
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
n=5 Participants
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Time to Maximum Plasma Concentration (Tmax)
Sacubitril
|
1.1 hours (hr)
Standard Deviation 1.3
|
1.2 hours (hr)
Standard Deviation 0.5
|
0.8 hours (hr)
Standard Deviation 0.3
|
1.2 hours (hr)
Standard Deviation 0.4
|
1.1 hours (hr)
Standard Deviation 0.1
|
1.0 hours (hr)
Standard Deviation 0.0
|
—
|
|
Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Time to Maximum Plasma Concentration (Tmax)
LBQ657
|
4.0 hours (hr)
Standard Deviation 2.0
|
2.9 hours (hr)
Standard Deviation 1.1
|
2.9 hours (hr)
Standard Deviation 1.1
|
3.6 hours (hr)
Standard Deviation 3.2
|
2.8 hours (hr)
Standard Deviation 1.6
|
3.6 hours (hr)
Standard Deviation 0.9
|
—
|
|
Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Time to Maximum Plasma Concentration (Tmax)
Valsartan
|
1.7 hours (hr)
Standard Deviation 1.1
|
2.1 hours (hr)
Standard Deviation 1.4
|
2.6 hours (hr)
Standard Deviation 1.0
|
1.9 hours (hr)
Standard Deviation 0.4
|
1.8 hours (hr)
Standard Deviation 1.5
|
1.8 hours (hr)
Standard Deviation 1.3
|
—
|
PRIMARY outcome
Timeframe: Age group 1: Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3: Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2Population: Participants in the Part 1 PK Set were analyzed.
The analyses of AUCinf was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The plasma levels of sacubitril/valsartan analytes were determined using a validated LCMS/MS method with a lower limit of quantitation (LLOQ) of 1 ng/mL for sacubitril, 20 ng/mL for LBQ657, and 10 ng/mL for valsartan. The PK parameters were determined using the non-compartmental method(s).
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=7 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
n=8 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
n=7 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
n=6 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
n=4 Participants
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
n=5 Participants
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)
Sacubitril
|
690 hr*ng/mL
Standard Deviation 410
|
494 hr*ng/mL
Standard Deviation 286
|
3021 hr*ng/mL
Standard Deviation 1814
|
1214 hr*ng/mL
Standard Deviation 684
|
270 hr*ng/mL
Standard Deviation 182
|
1063 hr*ng/mL
Standard Deviation 266
|
—
|
|
Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)
LBQ657
|
48264 hr*ng/mL
Standard Deviation 22939
|
31042 hr*ng/mL
Standard Deviation 17259
|
150440 hr*ng/mL
Standard Deviation 49515
|
127625 hr*ng/mL
Standard Deviation 35634
|
15835 hr*ng/mL
Standard Deviation 2912
|
62377 hr*ng/mL
Standard Deviation 16035
|
—
|
|
Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)
Valsartan
|
13540 hr*ng/mL
Standard Deviation 12962
|
11036 hr*ng/mL
Standard Deviation 7031
|
40733 hr*ng/mL
Standard Deviation 21003
|
48561 hr*ng/mL
Standard Deviation 21163
|
3923 hr*ng/mL
Standard Deviation 1424
|
26170 hr*ng/mL
Standard Deviation 16826
|
—
|
PRIMARY outcome
Timeframe: Age group 1: Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3: Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2Population: Participants in the Part 1 PK Set were analyzed.
As prespecified in protocol and SAP the analysis of this outcome measure was done based on dose of LCZ696 administered within the different age groups.
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=7 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
n=8 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
n=7 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
n=6 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
n=4 Participants
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
n=5 Participants
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Number of Participants With Area Under the Plasma Concentration-time Curve From Time Zero to Last (AUClast)
|
7 Participants
|
8 Participants
|
7 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: Age group 1: Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3: Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2Population: Participants in the Part 1 PK Set were analyzed.
The analyses was based on plasma concentrations of two sacubitril/valsartan analytes (AHU377 (sacubitril), and valsartan). The plasma levels of sacubitril/valsartan analytes were determined using a validated LCMS/MS method with a lower limit of quantitation (LLOQ) of 1 ng/mL for sacubitril, 20 ng/mL for LBQ657, and 10 ng/mL for valsartan. The PK parameters were determined using the non-compartmental method(s). CL/F was not estimated for LBQ657 as it is a metabolite.
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=7 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
n=8 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
n=7 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
n=6 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
n=4 Participants
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
n=5 Participants
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, and Valsartan): Clearance From Plasma (CL/F)
Sacubitril
|
0.73 liter per hour per kilograms (L/hr/kg)
Standard Deviation 0.35
|
1.19 liter per hour per kilograms (L/hr/kg)
Standard Deviation 0.96
|
0.63 liter per hour per kilograms (L/hr/kg)
Standard Deviation 0.28
|
1.67 liter per hour per kilograms (L/hr/kg)
Standard Deviation 1.01
|
1.19 liter per hour per kilograms (L/hr/kg)
Standard Deviation 1.11
|
1.67 liter per hour per kilograms (L/hr/kg)
Standard Deviation 1.01
|
—
|
|
Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril, and Valsartan): Clearance From Plasma (CL/F)
Valsartan
|
0.06 liter per hour per kilograms (L/hr/kg)
Standard Deviation 0.05
|
0.07 liter per hour per kilograms (L/hr/kg)
Standard Deviation 0.09
|
0.06 liter per hour per kilograms (L/hr/kg)
Standard Deviation 0.06
|
0.04 liter per hour per kilograms (L/hr/kg)
Standard Deviation 0.01
|
0.06 liter per hour per kilograms (L/hr/kg)
Standard Deviation 0.02
|
0.05 liter per hour per kilograms (L/hr/kg)
Standard Deviation 0.03
|
—
|
PRIMARY outcome
Timeframe: Age group 1: Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3: Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2Population: Part 1 PK Set. The overall number of participants analyzed is the number of participants with data available for this endpoint. T1/2 could not be determined for participants under the arm LCZ696: 0.4 mg/kg (Age Group 3) as their PK data was inadequate for the T1/2 calculation. As participants were from the age of 1 month to less than 1 year, it was difficult to obtain multiple PK samples.
The analyses of T1/2 was based on plasma concentrations of sacubitril. The plasma levels of sacubitril/valsartan analytes were determined using a validated LCMS/MS method with a lower limit of quantitation (LLOQ) of 1 ng/mL for sacubitril, 20 ng/mL for LBQ657, and 10 ng/mL for valsartan. The PK parameters were determined using the non-compartmental method(s). T1/2 for other analytes of LCZ696 (LBQ657 and Valsartan) was not estimable due to the short sample collection timeframe.
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=6 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
n=2 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
n=6 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
n=4 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
n=3 Participants
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Pharmacokinetics of LCZ696 Analytes (Sacubitril): Time Required to Drug Concentration to Decrease by Half (T 1/2)
|
1.26 hours
Interval 0.95 to 2.36
|
1.53 hours
Interval 1.4 to 1.65
|
1.34 hours
Interval 1.16 to 1.6
|
1.51 hours
Interval 1.34 to 1.7
|
—
|
1.33 hours
Interval 1.16 to 1.64
|
—
|
PRIMARY outcome
Timeframe: Baseline (0 hrs pre dose), 4 and 8 hrs post dose on Day 1 of Period 1 and Period 2Population: Part 1 PD set (PD1) included all participants who completed the Part 1 screening phase and had at least one dose of study drug during Part 1 of the study, at least one available PD measurement during Part 1 of the study and with no protocol deviations with relevant impact on PD data. Overall number of participants analyzed is the number of participants with data available for this endpoint.
Biomarkers were used to assess the PD effects of LCZ696. Blood biomarkers of potential interest included plasma BNP. Biomarkers related to heart failure or the mechanism of action of the study drug were measured. Summary statistics for change from baseline at each time point is presented. The baseline assessment is defined as the last non-missing assessment (scheduled or unscheduled) prior to (the first dose time of the study drug within the dose associated period). For each post-dose time point, participants are included if and only if the participant has both pre-dose assessment and current time point assessment observed.
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=6 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
n=6 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
n=7 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
n=3 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
n=3 Participants
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
n=4 Participants
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Pharmacodynamics (PD) of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Change From Baseline in Plasma B-type Natriuretic Peptide (BNP)
Baseline (0 hrs pre dose)
|
100.87 picomoles per liter (pmol/L)
Interval 49.84 to 204.13
|
63.80 picomoles per liter (pmol/L)
Interval 8.65 to 470.81
|
97.52 picomoles per liter (pmol/L)
Interval 51.59 to 184.32
|
120.51 picomoles per liter (pmol/L)
Interval 5.21 to 2787.44
|
21.20 picomoles per liter (pmol/L)
Interval 2.14 to 210.41
|
129.29 picomoles per liter (pmol/L)
Interval 9.45 to 1768.43
|
—
|
|
Part 1: Pharmacodynamics (PD) of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Change From Baseline in Plasma B-type Natriuretic Peptide (BNP)
Change From Baseline (4 hrs post dose)
|
1.31 picomoles per liter (pmol/L)
Interval 0.93 to 1.85
|
1.60 picomoles per liter (pmol/L)
Interval 0.21 to 11.95
|
1.22 picomoles per liter (pmol/L)
Interval 0.94 to 1.58
|
0.62 picomoles per liter (pmol/L)
The 95% confidence interval (CI) was not estimable for one participant
|
0.77 picomoles per liter (pmol/L)
Interval 0.56 to 1.05
|
1.09 picomoles per liter (pmol/L)
Interval 0.61 to 1.93
|
—
|
|
Part 1: Pharmacodynamics (PD) of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Change From Baseline in Plasma B-type Natriuretic Peptide (BNP)
Change From Baseline (8 hrs post dose)
|
1.32 picomoles per liter (pmol/L)
Interval 0.92 to 1.88
|
1.21 picomoles per liter (pmol/L)
Interval 0.21 to 7.04
|
0.97 picomoles per liter (pmol/L)
Interval 0.7 to 1.34
|
0.80 picomoles per liter (pmol/L)
The 95% CI was not estimable for one participant
|
0.59 picomoles per liter (pmol/L)
Interval 0.27 to 1.3
|
0.55 picomoles per liter (pmol/L)
Interval 0.15 to 2.02
|
—
|
PRIMARY outcome
Timeframe: Baseline (0 hrs pre dose) and optional 24 hrs post dosing on Day 1 of Period 1 and Period 2Population: Part 1 PD set. The overall number of participants analyzed is the number of participants with data available for this endpoint. Data has not been reported for the arms of LCZ696: 0.8 mg/kg (Age Group 2) and LCZ696: 3.1 mg/kg (Age Group 2) as no participants participated in the optional 24 hrs post-dose assessment.
Biomarkers were used to assess the PD effects of LCZ696. Blood biomarkers of potential interest included plasma NTproBNP. Biomarkers related to heart failure or the mechanism of action of the study drug were measured. Summary statistics for change from baseline at each time point is presented. The baseline assessment is defined as the last non-missing assessment (scheduled or unscheduled) prior to (the first dose time of the study drug within the dose associated period). For each post-dose time point, participants are included if and only if the participant has both pre-dose assessment and current time point assessment observed.
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=7 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
n=7 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
n=4 Participants
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
n=5 Participants
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Pharmacodynamics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Change From Baseline in Plasma N-terminal Pro-brain Natriuretic Peptide (NTproBNP)
Baseline (0 hrs pre dose)
|
2385.34 picograms per millilitre (pg/mL)
Interval 1186.13 to 4796.98
|
—
|
2179.94 picograms per millilitre (pg/mL)
Interval 932.77 to 5094.69
|
—
|
961.76 picograms per millilitre (pg/mL)
Interval 125.65 to 7361.7
|
5086.37 picograms per millilitre (pg/mL)
Interval 683.53 to 37849.47
|
—
|
|
Part 1: Pharmacodynamics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Change From Baseline in Plasma N-terminal Pro-brain Natriuretic Peptide (NTproBNP)
Change From Baseline (24 hrs post dose)
|
0.74 picograms per millilitre (pg/mL)
Interval 0.31 to 1.78
|
—
|
—
|
—
|
0.59 picograms per millilitre (pg/mL)
Interval 0.0 to 134.25
|
0.41 picograms per millilitre (pg/mL)
Interval 0.34 to 0.48
|
—
|
PRIMARY outcome
Timeframe: Baseline (0 hrs pre dose), 4 and 8 hrs post dose on Day 1 of Period 1 and Period 2Population: Part 1 PD set. The overall number of participants analyzed is the number of participants with data available for this endpoint.
Biomarkers were used to assess the PD effects of LCZ696. Blood biomarkers of potential interest included plasma cGMP. Biomarkers related to heart failure or the mechanism of action of the study drug were measured. Summary statistics for change from baseline at each time point is presented. The baseline assessment is defined as the last non-missing assessment (scheduled or unscheduled) prior to (the first dose time of the study drug within the dose associated period). For each post-dose time point, participants are included if and only if the participant has both pre-dose assessment and current time point assessment observed.
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=7 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
n=6 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
n=7 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
n=4 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
n=2 Participants
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
n=3 Participants
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Pharmacodynamics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Change From Baseline in Plasma Cyclic Guanosine Monophosphate (cGMP)
Baseline (0 hrs pre dose)
|
18.18 nanomoles per litre (nmol/L)
Interval 12.01 to 27.51
|
21.41 nanomoles per litre (nmol/L)
Interval 12.83 to 35.71
|
12.20 nanomoles per litre (nmol/L)
Interval 8.13 to 18.32
|
24.55 nanomoles per litre (nmol/L)
Interval 18.37 to 32.82
|
13.38 nanomoles per litre (nmol/L)
Interval 0.05 to 3883.59
|
22.84 nanomoles per litre (nmol/L)
Interval 12.51 to 41.68
|
—
|
|
Part 1: Pharmacodynamics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Change From Baseline in Plasma Cyclic Guanosine Monophosphate (cGMP)
Change From Baseline (4 hrs post dose)
|
1.30 nanomoles per litre (nmol/L)
Interval 0.89 to 1.9
|
0.90 nanomoles per litre (nmol/L)
Interval 0.5 to 1.62
|
1.54 nanomoles per litre (nmol/L)
Interval 1.12 to 2.1
|
1.02 nanomoles per litre (nmol/L)
Interval 0.52 to 2.01
|
0.80 nanomoles per litre (nmol/L)
Interval 0.0 to 618.02
|
0.78 nanomoles per litre (nmol/L)
Interval 0.27 to 2.22
|
—
|
|
Part 1: Pharmacodynamics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Change From Baseline in Plasma Cyclic Guanosine Monophosphate (cGMP)
Change From Baseline (8 hrs post dose)
|
1.17 nanomoles per litre (nmol/L)
Interval 0.91 to 1.5
|
0.92 nanomoles per litre (nmol/L)
Interval 0.66 to 1.29
|
1.60 nanomoles per litre (nmol/L)
Interval 1.1 to 2.31
|
0.40 nanomoles per litre (nmol/L)
Interval 0.02 to 8.86
|
0.79 nanomoles per litre (nmol/L)
Interval 0.0 to 230.1
|
0.79 nanomoles per litre (nmol/L)
Interval 0.29 to 2.18
|
—
|
PRIMARY outcome
Timeframe: Baseline (0 hrs pre dose), 4 to 8 hrs post dose on Day 1 of Period 1 and Period 2Population: Part 1 PD set. The overall number of participants analyzed is the number of participants with data available for this endpoint.
Biomarkers were used to assess the PD effects of LCZ696. Blood biomarkers of potential interest included urine cGMP. Biomarkers related to heart failure or the mechanism of action of the study drug were measured. Summary statistics for change from baseline at each time point is presented. The baseline assessment is defined as the last non-missing assessment (scheduled or unscheduled) prior to (the first dose time of the study drug within the dose associated period). For each post-dose time point, participants are included if and only if the participant has both pre-dose assessment and current time point assessment observed.
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=7 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
n=3 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
n=6 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
n=3 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
n=2 Participants
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
n=5 Participants
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Pharmacodynamics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Change From Baseline in Urine cGMP
Baseline (0 hrs pre dose)
|
1055.56 nmol/L
Interval 352.98 to 3156.55
|
1349.91 nmol/L
Interval 118.48 to 15380.33
|
914.57 nmol/L
Interval 311.65 to 2683.88
|
1123.69 nmol/L
Interval 75.21 to 16789.03
|
485.00 nmol/L
The 95% CI was not estimable for one participant
|
386.32 nmol/L
Interval 134.04 to 1113.42
|
—
|
|
Part 1: Pharmacodynamics of LCZ696 Analytes (Sacubitril, LBQ657, and Valsartan): Change From Baseline in Urine cGMP
Change From Baseline (4 to 8 hrs post dose)
|
1.42 nmol/L
Interval 0.38 to 5.32
|
0.80 nmol/L
Interval 0.02 to 27.03
|
1.79 nmol/L
Interval 0.65 to 4.96
|
2.17 nmol/L
Interval 0.1 to 45.16
|
0.92 nmol/L
Interval 0.02 to 51.75
|
1.98 nmol/L
Interval 0.51 to 7.63
|
—
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: Full analysis set included all randomized participants with the exception of those participants who had not been qualified for randomization and had not received study drug but had been inadvertently randomized into the study. A total of 377 participants were randomized in Part 2 of which a total of 375 were analyzed. Two participants who were excluded did not receive study drug and did not qualify for randomization.
Global ranking is based on 5 categories ranking worst to best outcome:Category 1:Death; United Network for Organ Sharing(UNOS)status 1A listing for heart transplant or equivalent; ventricular assist device(VAD)/extracorporeal membrane oxygenation(ECMO)/mechanical ventilation/intra-aortic balloon pump requirement for life support at end of study. Category 2:Worsening HF(WHF);defined by signs and symptoms of WHF that requires an intensification of HF therapy. Category 3:Worsened; worse New York Heart Association(NYHA)/Ross or worse Patient Global Impression of Severity(PGIS); and further ranking by Pediatric Quality of Life Inventory(PedsQL)physical functioning domain.Category 4:Unchanged; unchanged NYHA/Ross and unchanged PGIS; and further ranking by PedsQL physical functioning domain. Category 5:Improved; improved NYHA/Ross or improved PGIS(neither can be worse);and further ranking by PedsQL physical functioning domain. Participants with worst event in each category are reported here.
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=187 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
n=188 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 2: Percentage of Participants With Worst Event in Each Category Based on Global Ranking
Category 1
|
10.16 percentage of participants
|
15.96 percentage of participants
|
—
|
—
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—
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—
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—
|
|
Part 2: Percentage of Participants With Worst Event in Each Category Based on Global Ranking
Category 2
|
9.63 percentage of participants
|
4.79 percentage of participants
|
—
|
—
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—
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—
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—
|
|
Part 2: Percentage of Participants With Worst Event in Each Category Based on Global Ranking
Category 3
|
6.95 percentage of participants
|
5.85 percentage of participants
|
—
|
—
|
—
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—
|
—
|
|
Part 2: Percentage of Participants With Worst Event in Each Category Based on Global Ranking
Category 4
|
20.86 percentage of participants
|
26.60 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Worst Event in Each Category Based on Global Ranking
Category 5
|
39.57 percentage of participants
|
35.64 percentage of participants
|
—
|
—
|
—
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—
|
—
|
|
Part 2: Percentage of Participants With Worst Event in Each Category Based on Global Ranking
Missing
|
12.83 percentage of participants
|
11.17 percentage of participants
|
—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: From first dose to 30 days after last dose of study drug in Part 1Population: Part 1 Safety Analysis Set (SAF1) included all participants who completed the Part 1 screening phase and received at least one dose of study drug during Part 1 of the study.
An adverse event (AE) is any untoward medical occurrence associated with use of a drug in humans, whether considered drug related or not, that occurs after a participant provides informed consent. TEAEs during part 1 are defined as any recorded AE with its start date (recorded or imputed) later than or equal to the date of the first dose of the study drug within part 1 and its start date prior to or equal to the end date of the part 1.
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=7 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
n=6 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
n=7 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
n=6 Participants
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
n=4 Participants
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
n=5 Participants
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
n=2 Participants
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
|
28.57 percentage of participants
|
50.00 percentage of participants
|
28.57 percentage of participants
|
50.00 percentage of participants
|
50.00 percentage of participants
|
80.00 percentage of participants
|
50.00 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose to 30 days after last dose of study drug in Part 2 (up to 56 weeks)Population: Part 2: Safety Set included randomized participants who received at least one dose of study drug. Participants were analyzed according to the treatment actually received. A total of 377 participants were randomized in Part 2 of which a total of 375 were analyzed. Two participants who were excluded did not receive study drug and did not qualify for randomization.
An AE is any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. TEAEs during part 2 are defined as any recorded AE with its start date (recorded or imputed) later than or equal to the date of the first dose of the study drug within part 2 and its start date prior to or equal to the end date of part 2.
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=187 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
n=188 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 2: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
|
88.77 percentage of participant
|
87.77 percentage of participant
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full analysis set included all randomized participants with the exception of those participants who had not been qualified for randomization and had not received study drug but had been inadvertently randomized into the study. A total of 377 participants were randomized in Part 2 of which a total of 375 were analyzed. Two participants who were excluded did not receive study drug and did not qualify for randomization.
The exposure adjusted incidence rate is calculated as number of participants with at least one event divided by total participant years across all participants. Category 1: Death; UNOS status 1A listing for heart transplant or equivalent; VAD/ECMO/mechanical ventilation/intra-aortic balloon pump requirement for life support at end of study. Category 2: WHF; defined by signs and symptoms of WHF that requires an intensification of HF therapy.
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=34 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
n=33 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 2: Exposure-adjusted Incidence Rate of Category 1 or Category 2 Event
|
20.133 participant per participant years
Interval 13.943 to 28.1344
|
20.042 participant per participant years
Interval 13.796 to 28.1464
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 12, 24, 36, and 52Population: Participants in the full analysis set with available data were analyzed. The number analyzed is the number of participants with data available for analyses at specific timepoints. A total of 377 participants were randomized in Part 2 of which a total of 375 were analyzed. Two participants who were excluded did not receive study drug and did not qualify for randomization.
NYHA classification is a subjective physician's assessment of participant's functional capacity and symptomatic status and can change frequently over time. NYHA is tool that classifies participants with heart failure into one of four classes according to their degree of symptoms at rest and with activity. Class I: No limitations of physical activity. Class 2: May experience fatigue, palpitations, dyspnea, or angina during moderate exercise but not during rest. Class 3: Symptoms with minimal exertion that interfere with normal daily activity. Class 4: Unable to carry out any physical activity because they typically have symptoms of HF at rest that worsen with any exertion. Participants with change from baseline were classified as improved (shifted from higher to lower class), unchanged (no change in class) or worsened (shifted from lower to higher class).
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=187 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
n=188 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 2: Percentage of Participants With Change From Baseline in New York Heart Association (NYHA)/Ross Functional Class
Change from Baseline at Week 4: Improved
|
14.21 percentage of participants
|
15.67 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in New York Heart Association (NYHA)/Ross Functional Class
Change from Baseline at Week 4: Unchanged
|
84.15 percentage of participants
|
82.61 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in New York Heart Association (NYHA)/Ross Functional Class
Change from Baseline at Week 4: Worsened
|
1.64 percentage of participants
|
1.63 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in New York Heart Association (NYHA)/Ross Functional Class
Change from Baseline at Week 12: Improved
|
23.89 percentage of participants
|
25.56 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in New York Heart Association (NYHA)/Ross Functional Class
Change from Baseline at Week 12: Unchanged
|
70.56 percentage of participants
|
67.78 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in New York Heart Association (NYHA)/Ross Functional Class
Change from Baseline at Week 12: Worsened
|
5.56 percentage of participants
|
6.67 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in New York Heart Association (NYHA)/Ross Functional Class
Change from Baseline at Week 24: Improved
|
26.97 percentage of participants
|
27.91 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in New York Heart Association (NYHA)/Ross Functional Class
Change from Baseline at Week 24: Unchanged
|
64.04 percentage of participants
|
63.95 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in New York Heart Association (NYHA)/Ross Functional Class
Change from Baseline at Week 24: Worsened
|
8.99 percentage of participants
|
8.14 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in New York Heart Association (NYHA)/Ross Functional Class
Change from Baseline at Week 36: Improved
|
29.94 percentage of participants
|
34.12 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in New York Heart Association (NYHA)/Ross Functional Class
Change from Baseline at Week 36: Unchanged
|
61.08 percentage of participants
|
58.24 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in New York Heart Association (NYHA)/Ross Functional Class
Change from Baseline at Week 36: Worsened
|
8.98 percentage of participants
|
7.65 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in New York Heart Association (NYHA)/Ross Functional Class
Change from Baseline at Week 52: Improved
|
37.66 percentage of participants
|
33.96 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in New York Heart Association (NYHA)/Ross Functional Class
Change from Baseline at Week 52: Unchanged
|
50.65 percentage of participants
|
56.60 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in New York Heart Association (NYHA)/Ross Functional Class
Change from Baseline at Week 52: Worsened
|
11.69 percentage of participants
|
9.43 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 12, 24, 36, and 52Population: Participants in the full analysis set with available data were analyzed. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analyses at specific timepoints. A total of 377 participants were randomized in Part 2 of which a total of 375 were analyzed. Two participants who were excluded did not receive study drug and did not qualify for randomization.
PGIS of Heart Failure Symptoms is a 1-item questionnaire to assess the participant's impression of symptoms severity, specifically: shortness of breath, fatigue and swelling. The PGI-S asks the participant to choose one response that best describes how his/her heart failure symptoms, specifically: shortness of breath, fatigue and swelling are now on a 5-point scale, ranging from 'Not at all' (1) to 'Very severe' (5). C1 = none (good), C2 = mild, C3 = moderate, C4 = severe, C5 = very severe (bad). Percentage of participants by change in score are reported. Participants with change from baseline were classified as improved (shifted from higher to score), unchanged (no change in score) or worsened (shifted from lower to higher score).
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=182 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
n=188 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 2: Percentage of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) Score
Change from Baseline at Week 4: Improved
|
27.01 percentage of participants
|
29.67 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) Score
Change from Baseline at Week 4: Unchanged
|
58.05 percentage of participants
|
59.89 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) Score
Change from Baseline at Week 4: Worsened
|
14.94 percentage of participants
|
10.44 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) Score
Change from Baseline at Week 12: Improved
|
30.90 percentage of participants
|
31.46 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) Score
Change from Baseline at Week 12: Unchanged
|
52.25 percentage of participants
|
55.62 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) Score
Change from Baseline at Week 12: Worsened
|
16.85 percentage of participants
|
12.92 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) Score
Change from Baseline at Week 24: Improved
|
33.33 percentage of participants
|
38.01 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) Score
Change from Baseline at Week 24: Unchanged
|
48.85 percentage of participants
|
48.54 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) Score
Change from Baseline at Week 24: Worsened
|
17.82 percentage of participants
|
13.45 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) Score
Change from Baseline at Week 36: Improved
|
33.33 percentage of participants
|
33.94 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) Score
Change from Baseline at Week 36: Unchanged
|
49.38 percentage of participants
|
52.73 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) Score
Change from Baseline at Week 36: Worsened
|
17.28 percentage of participants
|
13.33 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) Score
Change from Baseline at Week 52: Improved
|
35.53 percentage of participants
|
34.81 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) Score
Change from Baseline at Week 52: Unchanged
|
48.03 percentage of participants
|
47.47 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Participants With Change From Baseline in Patient Global Impression of Severity (PGIS) Score
Change from Baseline at Week 52: Worsened
|
16.45 percentage of participants
|
17.72 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52Population: The Full Analysis Set included all randomized participants who received study drug, with the exception of \[2 patients in Part 2\] who had not received any study drug but had been inadvertently randomized into the study (mis-randomized).
The analyses of CL was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=203 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Clearance From Plasma (CL)
Sacubitril
|
25.93 L/h
Standard Deviation 19.29
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Clearance From Plasma (CL)
LBQ657
|
0.44 L/h
Standard Deviation 0.31
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Clearance From Plasma (CL)
Valsartan
|
1.97 L/h
Standard Deviation 1.69
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52Population: The Full Analysis Set included all randomized participants who received study drug, with the exception of \[2 patients in Part 2\] who had not received any study drug but had been inadvertently randomized into the study (mis-randomized).
The analyses of volume of distribution was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=203 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Volume of Distribution in Steady State
Sacubitril
|
4.67 L/Kg
Standard Deviation 5.84
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Volume of Distribution in Steady State
LBQ657
|
0.34 L/Kg
Standard Deviation 0.12
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Volume of Distribution in Steady State
Valsartan
|
0.68 L/Kg
Standard Deviation 0.29
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52Population: The Full Analysis Set included all randomized participants who received study drug, with the exception of \[2 patients in Part 2\] who had not received any study drug but had been inadvertently randomized into the study (mis-randomized).
The analyses of Ka was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=203 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Absorption Rate Constant (Ka)
Sacubitril
|
1.25 1/hour
Standard Deviation 0.01
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Absorption Rate Constant (Ka)
LBQ657
|
1.04 1/hour
Standard Deviation 1.34
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Absorption Rate Constant (Ka)
Valsartan
|
1.42 1/hour
Standard Deviation 0.92
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52Population: The Full Analysis Set included all randomized participants who received study drug, with the exception of \[2 patients in Part 2\] who had not received any study drug but had been inadvertently randomized into the study (mis-randomized).
The analyses of T1/2 was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=203 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Time Required to Drug Concentration to Decrease by Half (T 1/2)
Sacubitril
|
8.51 hours
Interval 1.87 to 199.55
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Time Required to Drug Concentration to Decrease by Half (T 1/2)
LBQ657
|
18.21 hours
Interval 6.08 to 107.47
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Time Required to Drug Concentration to Decrease by Half (T 1/2)
Valsartan
|
7.96 hours
Interval 2.33 to 81.65
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52Population: The Full Analysis Set included all randomized participants who received study drug, with the exception of \[2 patients in Part 2\] who had not received any study drug but had been inadvertently randomized into the study (mis-randomized).
The analyses of Cmax was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=203 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Maximum Drug Concentration in Plasma at Steady State (Cmax,ss)
Sacubitril
|
1348 ng/mL
Standard Deviation 627
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Maximum Drug Concentration in Plasma at Steady State (Cmax,ss)
LBQ657
|
10153 ng/mL
Standard Deviation 3591
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Maximum Drug Concentration in Plasma at Steady State (Cmax,ss)
Valsartan
|
3861 ng/mL
Standard Deviation 1770
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52Population: The Full Analysis Set included all randomized participants who received study drug, with the exception of \[2 patients in Part 2\] who had not received any study drug but had been inadvertently randomized into the study (mis-randomized).
The analyses of Cmin was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=203 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss)
Sacubitril
|
63 ng/mL
Standard Deviation 141
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss)
LBQ657
|
6442 ng/mL
Standard Deviation 3474
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss)
Valsartan
|
1442 ng/mL
Standard Deviation 1564
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Age group 1- Pre-dose and 0.5, 1, 2, 4, 8, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Age groups 2 and 3- Pre-dose and 1, 2, 4, 10, optional 24 hours post-dose on Day 1 of Period 1 and 2; Part 2: Weeks 2, 8, 12, 52Population: The Full Analysis Set included all randomized participants who received study drug, with the exception of \[2 patients in Part 2\] who had not received any study drug but had been inadvertently randomized into the study (mis-randomized).
The analyses of AUCtau was based on plasma concentrations of three sacubitril/valsartan analytes (AHU377 (sacubitril), LBQ657 (sacubitrilat), and valsartan). The PK parameters were determined using the non-compartmental method(s). In case of data limitations for estimating PK parameters using non-compartmental methods, a population PK approach was used to estimate exposure of sacubitril/valsartan analytes. The population PK model was developed to describe incoming data from pediatric patients based on an established model developed for the adult population.
Outcome measures
| Measure |
LCZ696: 0.8 mg/kg (Age Group 1)
n=203 Participants
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 0.8 mg/kg (Age Group 2)
Participants received LCZ696 0.8 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 1)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from the age of 6 to less than 18 years were included in this group.
|
LCZ696: 3.1 mg/kg (Age Group 2)
Participants received LCZ696 3.1 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age of 1 to less than 6 years were included in this group.
|
LCZ696: 0.4 mg/kg (Age Group 3)
Participants received LCZ696 0.4 mg/kg, given as a single oral dose on Day 1 of Period 1 in Part 1. Participants ranging from the age of 1 month to less than 1 year were included in this group.
|
LCZ696: 1.6 mg/kg (Age Group 3)
Participants received LCZ696 1.6 mg/kg, given as a single oral dose on Day 1 of Period 2 in Part 1. Participants ranging from age 1 month to 1 year were included in this group.
|
Part 1: Dose Cohort S
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
|---|---|---|---|---|---|---|---|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau at Steady State (AUCtau,ss)
Sacubitril
|
2179 ng/mL*h
Standard Deviation 2241
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau at Steady State (AUCtau,ss)
LBQ657
|
98906 ng/mL*h
Standard Deviation 41944
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Population PK of LCZ696 Analytes: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau at Steady State (AUCtau,ss)
Valsartan
|
28672 ng/mL*h
Standard Deviation 19686
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1: Dose Cohort 1
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1: Dose Cohort 2
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 1: Dose Cohort S
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2: LCZ696
Serious events: 69 serious events
Other events: 161 other events
Deaths: 8 deaths
Part 2: Enalapril
Serious events: 62 serious events
Other events: 156 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Part 1: Dose Cohort 1
n=17 participants at risk
Participants received LCZ696 0.4 mg/kg (age group 3 {1 month to \< 1 year}) or 0.8 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}), based on age, given as a single oral dose on Day 1 of period 1.
|
Part 1: Dose Cohort 2
n=18 participants at risk
Participants received LCZ696 1.6 mg/kg (age group 3 {1 month to \< 1 year}) or 3.1 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}), based on age, given as a single oral dose on Day 1 of period 2.
|
Part 1: Dose Cohort S
n=2 participants at risk
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
Part 2: LCZ696
n=187 participants at risk
Participants received LCZ696 3.1 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}) or 2.3 mg/kg (age group 3 {1 month to \< 1 year}), based on age, orally, twice a day (BID) for 52 weeks.
|
Part 2: Enalapril
n=188 participants at risk
Participants received enalapril 0.2 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}) or 0.15 mg/kg (age group 3 {1 month to \< 1 year}), based on age, orally, BID, for 52 weeks.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
12.8%
24/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
12.2%
23/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
5.9%
1/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Congenital, familial and genetic disorders
Adrenogenital syndrome
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.7%
5/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
General disorders
Chest pain
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
General disorders
Death
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
General disorders
Malaise
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
General disorders
Pyrexia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
General disorders
Sudden death
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Immune system disorders
Heart transplant rejection
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Influenza
|
5.9%
1/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.7%
5/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Septic shock
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Viral infection
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Viral sepsis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Blood urea increased
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Cardiac output decreased
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Coronavirus test positive
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Human rhinovirus test positive
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Weight decreased
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Weight increased
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Metabolism and nutrition disorders
Feeding intolerance
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Akinesia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Basal ganglia infarction
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Juvenile myoclonic epilepsy
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Neuromyopathy
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Seizure
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Vascular disorders
Haematoma
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Vascular disorders
Hypotension
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
Other adverse events
| Measure |
Part 1: Dose Cohort 1
n=17 participants at risk
Participants received LCZ696 0.4 mg/kg (age group 3 {1 month to \< 1 year}) or 0.8 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}), based on age, given as a single oral dose on Day 1 of period 1.
|
Part 1: Dose Cohort 2
n=18 participants at risk
Participants received LCZ696 1.6 mg/kg (age group 3 {1 month to \< 1 year}) or 3.1 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}), based on age, given as a single oral dose on Day 1 of period 2.
|
Part 1: Dose Cohort S
n=2 participants at risk
Participants in the dose cohort 2 who received LCZ696 3.1 mg/kg on Day 1 of period 2 and later received LCZ696 0.8 mg/kg, within period 2.
|
Part 2: LCZ696
n=187 participants at risk
Participants received LCZ696 3.1 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}) or 2.3 mg/kg (age group 3 {1 month to \< 1 year}), based on age, orally, twice a day (BID) for 52 weeks.
|
Part 2: Enalapril
n=188 participants at risk
Participants received enalapril 0.2 mg/kg (age group 1 {6 to \<18 years} and age group 2 {1 to \< 6 years}) or 0.15 mg/kg (age group 3 {1 month to \< 1 year}), based on age, orally, BID, for 52 weeks.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
11.1%
2/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.7%
7/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.7%
5/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.7%
5/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.2%
6/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Congenital, familial and genetic disorders
Phimosis
|
5.9%
1/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Eye disorders
Vision blurred
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
8.0%
15/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.9%
11/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.2%
6/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
4.8%
9/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.2%
6/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.7%
7/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
13.4%
25/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
12.2%
23/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.7%
5/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
4.8%
9/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
4.8%
9/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.7%
5/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
22.2%
4/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
50.0%
1/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
17.6%
33/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
19.7%
37/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
General disorders
Asthenia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
General disorders
Chest discomfort
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
General disorders
Chest pain
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.7%
7/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.7%
7/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
General disorders
Face oedema
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
General disorders
Fatigue
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
50.0%
1/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
10.2%
19/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
7.4%
14/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
General disorders
Medical device pain
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
General disorders
Oedema peripheral
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.7%
7/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
General disorders
Peripheral swelling
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
50.0%
1/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
General disorders
Pyrexia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
19.3%
36/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
18.1%
34/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
General disorders
Swelling face
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
50.0%
1/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
6.4%
12/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
4.3%
8/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
COVID-19
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.2%
6/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Candida infection
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Ear infection
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Exanthema subitum
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
4.8%
9/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.9%
11/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Influenza
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.9%
11/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
6.4%
12/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
15.5%
29/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
9.0%
17/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Otitis media
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.7%
5/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.2%
6/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.7%
5/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
5.9%
1/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.7%
5/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.7%
7/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.3%
10/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
16.7%
3/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
50.0%
1/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
19.8%
37/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
18.6%
35/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Viral infection
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.7%
5/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.7%
5/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Blood creatine increased
|
5.9%
1/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.2%
6/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.7%
5/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Blood potassium increased
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Blood urea increased
|
5.9%
1/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Blood uric acid increased
|
5.9%
1/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Body temperature increased
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
4.8%
9/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
6.4%
12/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
SARS-CoV-2 test negative
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.2%
6/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Weight decreased
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Investigations
Weight increased
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
4.8%
9/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.2%
6/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.2%
6/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.2%
6/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.2%
6/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
12.3%
23/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
8.0%
15/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
11.8%
22/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
10.6%
20/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Migraine
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.7%
5/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Psychiatric disorders
Depression
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Renal and urinary disorders
Renal failure
|
5.9%
1/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
50.0%
1/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
19.3%
36/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
20.2%
38/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.2%
6/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
1/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
4.8%
9/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.2%
6/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
4.8%
9/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.7%
5/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.7%
5/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.7%
7/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.7%
7/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.1%
4/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.6%
3/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
2.7%
5/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
3.2%
6/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Vascular disorders
Hypertension
|
0.00%
0/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.53%
1/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
1.1%
2/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
|
Vascular disorders
Hypotension
|
5.9%
1/17 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
11.1%
2/18 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
0.00%
0/2 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
11.2%
21/187 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
11.7%
22/188 • Adverse events were collected from first dose of study treatment plus 30 days post treatment up to approximately one year.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. Of the 26 participants enrolled in Part 1, all 26 participants received at least one dose of study medication. Of the 377 participants enrolled in Part 2, 375 received study medication. 2 participants in the Enalapril arm were mis-randomized in error; therefore, did not receive any medication.
|
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 or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER