Trial Outcomes & Findings for Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants (NCT NCT01180790)
NCT ID: NCT01180790
Last Updated: 2023-08-30
Results Overview
Segment 1: Percentage of participants with the following: adverse events, abnormal laboratory safety tests, dose reductions, interruptions, and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening Division of AIDS (Acquired Immunodeficiency Syndrome) (DAIDs) graded laboratory tests. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
4 weeks
Results posted on
2023-08-30
Participant Flow
Participants were recruited from 15 sites in the United States and 3 sites in Belgium between 30 September 2010 and 03 January 2012.
Participants were screened within 4 weeks (Day -28 to Day -1) before administration of the study drug. Participants who meet all eligibility criteria were instructed to arrive at the study center on Baseline day for randomization to treatment assignment.
Participant milestones
| Measure |
Segment 1: 200 Milligrams (mg) ACH-0141625 for 28 Days
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon (Peg-IFN) alpha-2a: 180 micrograms (ug) once a week by subcutaneous injection for 48 weeks
Ribavirin (RBV): 400 mg or 600 mg (morning \[AM\]) and 600 mg (evening \[PM\]) capsules taken orally twice daily for 48 weeks
|
Segment 1: 400 mg ACH-0141625 for 28 Days
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
|
Segment 1: 800 mg ACH-0141625 for 28 Days
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
|
Segment 1: Placebo for 28 Days
Placebo: Powder in capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
|
Segment 2: 200 mg ACH-0141625 for 12 Weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for up to 24 or 48 weeks
|
Segment 2: 400 mg ACH-0141625 for 12 Weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for up to 24 or 48 weeks
|
Segment 2: 800 mg ACH-0141625 for 12 Weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for up to 24 or 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
17
|
15
|
19
|
20
|
19
|
|
Overall Study
COMPLETED
|
7
|
11
|
4
|
6
|
14
|
13
|
18
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
13
|
9
|
5
|
7
|
1
|
Reasons for withdrawal
| Measure |
Segment 1: 200 Milligrams (mg) ACH-0141625 for 28 Days
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon (Peg-IFN) alpha-2a: 180 micrograms (ug) once a week by subcutaneous injection for 48 weeks
Ribavirin (RBV): 400 mg or 600 mg (morning \[AM\]) and 600 mg (evening \[PM\]) capsules taken orally twice daily for 48 weeks
|
Segment 1: 400 mg ACH-0141625 for 28 Days
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
|
Segment 1: 800 mg ACH-0141625 for 28 Days
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
|
Segment 1: Placebo for 28 Days
Placebo: Powder in capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
|
Segment 2: 200 mg ACH-0141625 for 12 Weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for up to 24 or 48 weeks
|
Segment 2: 400 mg ACH-0141625 for 12 Weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for up to 24 or 48 weeks
|
Segment 2: 800 mg ACH-0141625 for 12 Weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for up to 24 or 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
2
|
0
|
1
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
5
|
0
|
2
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
0
|
2
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
5
|
6
|
1
|
3
|
0
|
|
Overall Study
compliance
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Severe coronary atherosclerosis (death)
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants
Baseline characteristics by cohort
| Measure |
Segment 1: 200 mg ACH-0141625
n=16 Participants
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and RBV for 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
|
Segment 1: 400 mg ACH-0141625
n=16 Participants
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
|
Segment 1: 800 mg ACH-0141625
n=17 Participants
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
|
Segment 1: Placebo
n=15 Participants
Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
Placebo: Powder in capsule once daily for 28 days
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
|
Segment 2: 200 mg ACH-0141625
n=19 Participants
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 48 weeks
ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
|
Segment 2: 400 mg ACH-0141625
n=20 Participants
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 48 weeks
ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
|
Segment 2: 800 mg ACH-0141625
n=19 Participants
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 48 weeks
ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
119 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 7 • n=5 Participants
|
51 years
STANDARD_DEVIATION 9 • n=7 Participants
|
52 years
STANDARD_DEVIATION 13 • n=5 Participants
|
47 years
STANDARD_DEVIATION 9 • n=4 Participants
|
45 years
STANDARD_DEVIATION 11 • n=21 Participants
|
48 years
STANDARD_DEVIATION 12 • n=8 Participants
|
42 years
STANDARD_DEVIATION 12 • n=8 Participants
|
48 years
STANDARD_DEVIATION 11 • n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
38 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
84 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The safety population, which was defined as all participants randomized and treated with at least one dose of ACH-0141625 or Placebo. Participants were analyzed according to the randomized treatment.
Segment 1: Percentage of participants with the following: adverse events, abnormal laboratory safety tests, dose reductions, interruptions, and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening Division of AIDS (Acquired Immunodeficiency Syndrome) (DAIDs) graded laboratory tests. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Segment 1: Placebo
n=15 Participants
Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 200 mg ACH-0141625
n=16 Participants
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 400 mg ACH-0141625
n=16 Participants
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 800 mg ACH-0141625
n=17 Participants
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 2: 200 mg ACH-0141625
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 400 mg ACH-0141625
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 800 mg ACH-0141625
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
|---|---|---|---|---|---|---|---|
|
Segment 1: Safety
Adverse Events (%)
|
93.3 percentage of participants
|
100.0 percentage of participants
|
93.8 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
—
|
|
Segment 1: Safety
Abnormal Laboratories (%)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
94.0 percentage of participants
|
—
|
—
|
—
|
|
Segment 1: Safety
Dose Reductions (%)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Segment 1: Safety
Dose Interruptions (%)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Segment 1: Safety
Dose Discontinuations (%)
|
0 percentage of participants
|
6.0 percentage of participants
|
0 percentage of participants
|
6.0 percentage of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Efficacy analysis was performed on the virology population (a subset of the ITT population) and included all participants who had a baseline HCV RNA result and at least 1 post-baseline HCV RNA result.
The primary efficacy endpoint for Segment 1 of the study was the percentage of participants in each treatment group achieving RVR4 (hepatitis C virus \[HCV\] ribonucleic acid (RNA) less than or equal to the limit of quantitation \[LOQ\] at the Week 4 visit).
Outcome measures
| Measure |
Segment 1: Placebo
n=15 Participants
Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 200 mg ACH-0141625
n=16 Participants
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 400 mg ACH-0141625
n=16 Participants
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 800 mg ACH-0141625
n=17 Participants
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 2: 200 mg ACH-0141625
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 400 mg ACH-0141625
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 800 mg ACH-0141625
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
|---|---|---|---|---|---|---|---|
|
Segment 1: Rapid Viral Response At Week 4 (RVR4)
Rapid Virologic Response (%)
|
20.0 percentage of participants
|
75.0 percentage of participants
|
75.0 percentage of participants
|
76.5 percentage of participants
|
—
|
—
|
—
|
|
Segment 1: Rapid Viral Response At Week 4 (RVR4)
No Rapid Virologic Response (%)
|
80.0 percentage of participants
|
25.0 percentage of participants
|
25.0 percentage of participants
|
23.5 percentage of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The safety population, which was defined as all participants randomized and treated with at least 1 dose of ACH-0141625. Participants were analyzed according to the randomized treatment.
Segment 2: Percentage of participants with the following: adverse events, abnormal laboratory safety tests and dose reductions, interruptions and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening DAIDs graded laboratory tests. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Segment 1: Placebo
n=19 Participants
Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 200 mg ACH-0141625
n=20 Participants
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 400 mg ACH-0141625
n=19 Participants
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 800 mg ACH-0141625
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 2: 200 mg ACH-0141625
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 400 mg ACH-0141625
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 800 mg ACH-0141625
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
|---|---|---|---|---|---|---|---|
|
Segment 2: Safety
Adverse Events (%)
|
94.7 percentage of participants
|
85.0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Segment 2: Safety
Abnormal Laboratories (%)
|
100.0 percentage of participants
|
95.0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Segment 2: Safety
Dose Reductions (%)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Segment 2: Safety
Dose Interruptions (%)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Segment 2: Safety
Dose Discontinuations (%)
|
6.0 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 12Population: Per protocol virology population (a subset of the virology population) and included all randomized participants who completed 12 weeks of ACH-0141625 dosing.
The primary efficacy endpoint for Segment 2 of the study was the percentage of participants achieving cEVR, defined as undetectable HCV RNA at Week 12.
Outcome measures
| Measure |
Segment 1: Placebo
n=18 Participants
Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 200 mg ACH-0141625
n=16 Participants
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 400 mg ACH-0141625
n=19 Participants
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 800 mg ACH-0141625
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 2: 200 mg ACH-0141625
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 400 mg ACH-0141625
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 800 mg ACH-0141625
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
|---|---|---|---|---|---|---|---|
|
Segment 2: Complete Early Virologic Response (cEVR)
|
100.0 percentage of participants
|
94.0 percentage of participants
|
100.00 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Analysis for Segment 1 was performed on the virology population (the same as the ITT population) and included all participants who had a baseline HCV RNA result and at least 1 post-baseline HCV RNA result.
For Segment 1, the percentage of participants in the virology population who achieved cEVR, defined as undetectable HCV RNA at Week 12.
Outcome measures
| Measure |
Segment 1: Placebo
n=16 Participants
Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 200 mg ACH-0141625
n=16 Participants
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 400 mg ACH-0141625
n=17 Participants
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 800 mg ACH-0141625
n=15 Participants
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 2: 200 mg ACH-0141625
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 400 mg ACH-0141625
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 800 mg ACH-0141625
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
|---|---|---|---|---|---|---|---|
|
Segment 1: cEVR
|
62.5 percentage of participants
|
75.0 percentage of participants
|
70.6 percentage of participants
|
33.3 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Per protocol virology population (a subset of the virology population) and included all randomized participants who completed 4 weeks of ACH-0141625 dosing.
For Segment 2, the percentage of participants in the virology population who achieved RVR4, defined as HCV RNA less than or equal to the LOQ at the Week 4 visit.
Outcome measures
| Measure |
Segment 1: Placebo
n=19 Participants
Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 200 mg ACH-0141625
n=18 Participants
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 400 mg ACH-0141625
n=19 Participants
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 800 mg ACH-0141625
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 2: 200 mg ACH-0141625
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 400 mg ACH-0141625
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 800 mg ACH-0141625
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
|---|---|---|---|---|---|---|---|
|
Segment 2: RVR4
|
78.9 percentage of participants
|
88.8 percentage of participants
|
89.5 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48 (Segment 1); Week 24 (Segment 2)Population: Segment 2 analyzed the per protocol population (PPP), which includes all randomized participants who completed 12 weeks of ACH-0141625 dosing and an additional 12 weeks of Peg/RBV dosing.
The percentage of virology population participants who were reported as undetectable HCV RNA at the completion of treatment.
Outcome measures
| Measure |
Segment 1: Placebo
n=16 Participants
Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 200 mg ACH-0141625
n=16 Participants
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 400 mg ACH-0141625
n=17 Participants
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 800 mg ACH-0141625
n=15 Participants
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 2: 200 mg ACH-0141625
n=12 Participants
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 400 mg ACH-0141625
n=13 Participants
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 800 mg ACH-0141625
n=14 Participants
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
|---|---|---|---|---|---|---|---|
|
Segment 1 And Segment 2: End Of Treatment Response
|
75.0 percentage of participants
|
75.0 percentage of participants
|
64.7 percentage of participants
|
53.3 percentage of participants
|
100.0 percentage of participants
|
92.3 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: 3 months post-dosingPopulation: Segment 2 analyzed the PPP (all randomized participants completing 12 weeks of ACH-0141625 + an extra 12 weeks of Peg/RBV) who returned for SVR12.
The percentage of virology population participants who achieved sustained virologic response (SVR), defined as HCV RNA less than the LOQ, at 12 weeks (3 months) post-dosing.
Outcome measures
| Measure |
Segment 1: Placebo
n=16 Participants
Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 200 mg ACH-0141625
n=16 Participants
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 400 mg ACH-0141625
n=17 Participants
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 800 mg ACH-0141625
n=15 Participants
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 2: 200 mg ACH-0141625
n=10 Participants
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 400 mg ACH-0141625
n=13 Participants
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 800 mg ACH-0141625
n=13 Participants
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
|---|---|---|---|---|---|---|---|
|
Segment 1 And Segment 2: Sustained Virologic Response 12 Weeks (3 Months Post-dosing) (SVR12)
|
56.3 percentage of participants
|
56.3 percentage of participants
|
35.3 percentage of participants
|
40.0 percentage of participants
|
80.0 percentage of participants
|
76.9 percentage of participants
|
84.5 percentage of participants
|
SECONDARY outcome
Timeframe: 6 months post-dosingPopulation: Segment 2 analyzed the PPP (all randomized participants completing 12 weeks of ACH-0141625 plus an extra 12 weeks of Peg/RBV) who returned for SVR24
The percentage of virology population participants who achieved SVR, defined as HCV RNA less than the LOQ, 6 months post-dosing.
Outcome measures
| Measure |
Segment 1: Placebo
n=16 Participants
Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 200 mg ACH-0141625
n=16 Participants
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 400 mg ACH-0141625
n=17 Participants
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 800 mg ACH-0141625
n=15 Participants
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 2: 200 mg ACH-0141625
n=10 Participants
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 400 mg ACH-0141625
n=13 Participants
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 800 mg ACH-0141625
n=12 Participants
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
|---|---|---|---|---|---|---|---|
|
Segment 1 And Segment 2: Sustained Virologic Response 24 Weeks (6 Months Post-dosing) (SVR24)
|
62.5 percentage of participants
|
56.3 percentage of participants
|
35.3 percentage of participants
|
40.0 percentage of participants
|
70.0 percentage of participants
|
76.9 percentage of participants
|
83.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: Efficacy analysis was performed on the virology population, which was a subset of the ITT population and included all participants who had a baseline HCV RNA result and at least 1 post-baseline HCV RNA result.
The mean change from baseline in log10 HCV RNA level by visit for the virology population
Outcome measures
| Measure |
Segment 1: Placebo
n=13 Participants
Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 200 mg ACH-0141625
n=15 Participants
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 400 mg ACH-0141625
n=16 Participants
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 800 mg ACH-0141625
n=15 Participants
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 2: 200 mg ACH-0141625
n=19 Participants
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 400 mg ACH-0141625
n=18 Participants
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 800 mg ACH-0141625
n=19 Participants
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
|---|---|---|---|---|---|---|---|
|
Segment 1 And Segment 2: HCV RNA Change From Baseline
|
-4.94 log10 HCV RNA Level
Standard Deviation 0.993
|
-4.60 log10 HCV RNA Level
Standard Deviation 1.462
|
-4.94 log10 HCV RNA Level
Standard Deviation 1.098
|
-2.22 log10 HCV RNA Level
Standard Deviation 1.447
|
-4.74 log10 HCV RNA Level
Standard Deviation 1.072
|
-5.04 log10 HCV RNA Level
Standard Deviation 0.738
|
-4.51 log10 HCV RNA Level
Standard Deviation 0.941
|
SECONDARY outcome
Timeframe: Week 12Population: Efficacy analysis was performed on the virology population, a subset of the ITT population, and included all participants who had a baseline HCV RNA result and at least 1 post-baseline HCV RNA result.
Change from baseline in log10 HCV RNA level by visit.
Outcome measures
| Measure |
Segment 1: Placebo
n=13 Participants
Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
Placebo: Powder in capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 200 mg ACH-0141625
n=14 Participants
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 400 mg ACH-0141625
n=11 Participants
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 1: 800 mg ACH-0141625
n=15 Participants
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection
ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
|
Segment 2: 200 mg ACH-0141625
n=18 Participants
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 400 mg ACH-0141625
n=16 Participants
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 800 mg ACH-0141625
n=18 Participants
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
|---|---|---|---|---|---|---|---|
|
Segment 1 And Segment 2: HCV RNA Change From Baseline
|
-5.13 log10 HCV RNA level
Standard Deviation 0.518
|
-4.51 log10 HCV RNA level
Standard Deviation 1.467
|
-4.67 log10 HCV RNA level
Standard Deviation 1.555
|
-3.48 log10 HCV RNA level
Standard Deviation 1.753
|
-4.90 log10 HCV RNA level
Standard Deviation 1.104
|
-5.08 log10 HCV RNA level
Standard Deviation 0.770
|
-4.58 log10 HCV RNA level
Standard Deviation 0.946
|
Adverse Events
Segment 1: 200 mg ACH-0141625
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Segment 1: 400 mg ACH-0141625
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Segment 1: 800 mg ACH-0141625
Serious events: 5 serious events
Other events: 17 other events
Deaths: 0 deaths
Segment 2: 200 mg ACH-0141625
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Segment 2: 400 mg ACH-0141625
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Segment 2: 800 mg ACH-0141625
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Segment 1: Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Segment 1: 200 mg ACH-0141625
n=16 participants at risk
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and RBV for 48 weeks
ACH-0141625: 200 mg oral capsule
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 1: 400 mg ACH-0141625
n=16 participants at risk
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
|
Segment 1: 800 mg ACH-0141625
n=17 participants at risk
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 200 mg ACH-0141625
n=19 participants at risk
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 400 mg ACH-0141625
n=20 participants at risk
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 800 mg ACH-0141625
n=19 participants at risk
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 1: Placebo
n=15 participants at risk
Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
Placebo: Powder in capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Ischemic Colitis
|
6.2%
1/16 • Number of events 1 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Infections and infestations
Bacteremia
|
6.2%
1/16 • Number of events 1 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
General disorders
Chest Pain
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Number of events 1 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Mania
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Number of events 1 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Number of events 1 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Cardiac disorders
Severe Coronary Atherosclerosis MI (death)
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Number of events 1 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Exacerbation of schizophrenia
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Number of events 1 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Vascular disorders
Left Lower Extremity Deep Vein Thrombosis
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Number of events 1 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Number of events 1 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Depression
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Number of events 1 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
Other adverse events
| Measure |
Segment 1: 200 mg ACH-0141625
n=16 participants at risk
200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and RBV for 48 weeks
ACH-0141625: 200 mg oral capsule
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 1: 400 mg ACH-0141625
n=16 participants at risk
400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily for 48 weeks
|
Segment 1: 800 mg ACH-0141625
n=17 participants at risk
800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 200 mg ACH-0141625
n=19 participants at risk
200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 200 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 400 mg ACH-0141625
n=20 participants at risk
400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 400 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 2: 800 mg ACH-0141625
n=19 participants at risk
800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
ACH-0141625: 800 mg oral capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
Segment 1: Placebo
n=15 participants at risk
Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks
Placebo: Powder in capsule once daily
Peg-IFN alpha-2a: 180 ug once a week by subcutaneous injection
RBV: 400 mg or 600 mg (AM) and 600 mg (PM) capsules taken orally twice daily
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
25.0%
4/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
17.6%
3/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
20.0%
3/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Blood and lymphatic system disorders
Haemoglobinaemia
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
17.6%
3/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
25.0%
5/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
26.3%
5/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
26.7%
4/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Ear and labyrinth disorders
Ear discomfort
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Eye disorders
Dry eye
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Eye disorders
Eye irritation
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Eye disorders
Eye pain
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Eye disorders
Photophobia
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Eye disorders
Vision blurred
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
11.8%
2/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
13.3%
2/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
11.8%
2/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
13.3%
2/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Diarrhoea
|
31.2%
5/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
18.8%
3/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
23.5%
4/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.0%
2/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
13.3%
2/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Dyspepsia
|
18.8%
3/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
15.8%
3/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.0%
2/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Nausea
|
31.2%
5/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
31.2%
5/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
47.1%
8/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
26.3%
5/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
45.0%
9/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
63.2%
12/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
26.7%
4/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Toothache
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
11.8%
2/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.0%
2/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
General disorders
Application site erythema
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
General disorders
Asthenia
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
General disorders
Chest pain
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
General disorders
Chills
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
17.6%
3/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
13.3%
2/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
General disorders
Fatigue
|
31.2%
5/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
43.8%
7/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
41.2%
7/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
47.4%
9/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
45.0%
9/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
52.6%
10/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
33.3%
5/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
General disorders
Influenza like illness
|
37.5%
6/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
29.4%
5/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
21.1%
4/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
20.0%
4/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
15.8%
3/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
General disorders
Injection site erythema
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
23.5%
4/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
20.0%
3/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
General disorders
Injection site haematoma
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
General disorders
Injection site irritation
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
General disorders
Injection site pain
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
General disorders
Injection site pruritus
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
General disorders
Injection site rash
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
General disorders
Injection site reaction
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
General disorders
Irritability
|
18.8%
3/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
18.8%
3/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
11.8%
2/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.0%
2/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
26.3%
5/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
General disorders
Pain
|
18.8%
3/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
18.8%
3/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
23.5%
4/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
15.0%
3/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
15.8%
3/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
General disorders
Pyrexia
|
25.0%
4/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
18.8%
3/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.0%
2/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
21.1%
4/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Infections and infestations
Impetigo
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
11.8%
2/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Injury, poisoning and procedural complications
Wound
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Investigations
Creatinine renal clearance decreased
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Investigations
Haemoglobin decreased
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Investigations
Transaminases increased
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
18.8%
3/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
11.8%
2/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
26.3%
5/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
25.0%
5/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
21.1%
4/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Metabolism and nutrition disorders
Insulin resistance
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
4/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
11.8%
2/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
15.8%
3/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.0%
2/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
13.3%
2/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
15.8%
3/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
4/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
21.1%
4/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
20.0%
4/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
13.3%
2/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.0%
2/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Nervous system disorders
Disturbance in attention
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
11.8%
2/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
11.8%
2/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Nervous system disorders
Dysgeusia
|
18.8%
3/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Nervous system disorders
Headache
|
50.0%
8/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
43.8%
7/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
29.4%
5/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
21.1%
4/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
30.0%
6/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
47.4%
9/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
33.3%
5/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Nervous system disorders
Migraine
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.0%
2/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Agitation
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
17.6%
3/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
20.0%
4/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.0%
2/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Depression
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
11.8%
2/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Insomnia
|
25.0%
4/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
11.8%
2/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
15.8%
3/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
25.0%
5/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
26.3%
5/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
20.0%
3/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Libido decreased
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Mania
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Mood swings
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Sleep terror
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Psychiatric disorders
Tearfulness
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Renal and urinary disorders
Dysuria
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
18.8%
3/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
15.0%
3/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
13.3%
2/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
17.6%
3/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
20.0%
4/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
15.8%
3/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.0%
2/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
12.5%
2/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
10.5%
2/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
15.8%
3/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
13.3%
2/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.7%
1/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Skin and subcutaneous tissue disorders
Skin chapped
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.9%
1/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
|
Vascular disorders
Hot flush
|
0.00%
0/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
6.2%
1/16 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/17 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.3%
1/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
5.0%
1/20 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
0.00%
0/19 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
13.3%
2/15 • Adverse event data collected through end of treatment plus 4 weeks.
Treatment-emergent AEs presented: Day 1 through end of ACH-0141625/placebo treatment period plus 14 days. All serious adverse events (SAEs) reported during the study period are presented.
|
Additional Information
Alexion Pharmaceuticals Inc.
Alexion Pharmaceuticals Inc.
Phone: 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to submitting/presenting a manuscript or materials relating to a Study to a publisher, reviewer, or outside person, the Institution shall provide to Sponsor a copy of all such manuscripts or materials, and Sponsor shall have sixty (60) days to review and comment. The Institution shall, upon Sponsor's request, further delay publication or presentation for a period of up to one hundred twenty (120) days to allow Sponsor to protect its interests in any Sponsor Inventions.
- Publication restrictions are in place
Restriction type: OTHER