Trial Outcomes & Findings for Standard of Care (SOC) With or Without CTS-1027 in Hepatitis C (HCV) Null-Responders (NCT NCT01273064)
NCT ID: NCT01273064
Last Updated: 2012-06-11
Results Overview
Percent of patients that achieve a sustained virologic response (SVR) at Week 72 defined as HCV-RNA (Hepatitis C virus ribonucleic acid, also known as 'viral load') level below the quantification limit (BQL) at Week 72.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
114 participants
Primary outcome timeframe
Baseline and 24 weeks after the end of treatment (Week 72)
Results posted on
2012-06-11
Participant Flow
Participant milestones
| Measure |
CTS-1027 60 mg + Ribavirin + Peglyated Interferon
Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
|
CTS-1027 30 mg + Ribavirin + Pegylated Interferon
Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
|
CTS-1027 15 mg + Ribavirin + Pegylated Interferon
Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
|
Placebo + Ribavirin + Pegylated Interferon
Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
|
Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon
Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
30
|
31
|
20
|
10
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
23
|
30
|
31
|
20
|
10
|
Reasons for withdrawal
| Measure |
CTS-1027 60 mg + Ribavirin + Peglyated Interferon
Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
|
CTS-1027 30 mg + Ribavirin + Pegylated Interferon
Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
|
CTS-1027 15 mg + Ribavirin + Pegylated Interferon
Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
|
Placebo + Ribavirin + Pegylated Interferon
Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
|
Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon
Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
3
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
2
|
2
|
0
|
|
Overall Study
Study Termination
|
13
|
27
|
26
|
16
|
8
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Standard of Care (SOC) With or Without CTS-1027 in Hepatitis C (HCV) Null-Responders
Baseline characteristics by cohort
| Measure |
CTS-1027 60 mg + Ribavirin + Peglyated Interferon
n=23 Participants
Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
|
CTS-1027 30 mg + Ribavirin + Pegylated Interferon
n=30 Participants
Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
|
CTS-1027 15 mg + Ribavirin + Pegylated Interferon
n=31 Participants
Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
|
Placebo + Ribavirin + Pegylated Interferon
n=20 Participants
Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
|
Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon
n=10 Participants
Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
108 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
|
Age Continuous
|
53.1 years
STANDARD_DEVIATION 7.0 • n=93 Participants
|
55.1 years
STANDARD_DEVIATION 6.0 • n=4 Participants
|
50.5 years
STANDARD_DEVIATION 11.3 • n=27 Participants
|
52.8 years
STANDARD_DEVIATION 7.1 • n=483 Participants
|
57.7 years
STANDARD_DEVIATION 5.9 • n=36 Participants
|
53.2 years
STANDARD_DEVIATION 8.3 • n=10 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
41 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
73 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=93 Participants
|
30 participants
n=4 Participants
|
31 participants
n=27 Participants
|
20 participants
n=483 Participants
|
10 participants
n=36 Participants
|
114 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeks after the end of treatment (Week 72)Population: Due to the premature discontinuation of this study and termination of the entire CTS-1027 program, an efficacy analysis was not conducted. No patients completed the study.
Percent of patients that achieve a sustained virologic response (SVR) at Week 72 defined as HCV-RNA (Hepatitis C virus ribonucleic acid, also known as 'viral load') level below the quantification limit (BQL) at Week 72.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, and Study Weeks 12, 24, and 48Population: Due to the premature discontinuation of this study and termination of the entire CTS-1027 program, an efficacy analysis was not conducted. No patients completed the study.
Percent of patients experiencing a drop in Hepatitis C virus ribonucleic acid (HCV-RNA, also known as "viral load") levels in the blood equal to, or greater than, 2 log from before treatment (baseline) through 12, 24, and 48 weeks of treatment.
Outcome measures
Outcome data not reported
Adverse Events
CTS-1027 60 mg + Ribavirin + Peglyated Interferon
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
CTS-1027 30 mg + Ribavirin + Pegylated Interferon
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
CTS-1027 15 mg + Ribavirin + Pegylated Interferon
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo + Ribavirin + Pegylated Interferon
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CTS-1027 60 mg + Ribavirin + Peglyated Interferon
n=23 participants at risk
Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
|
CTS-1027 30 mg + Ribavirin + Pegylated Interferon
n=30 participants at risk
Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
|
CTS-1027 15 mg + Ribavirin + Pegylated Interferon
n=31 participants at risk
Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
|
Placebo + Ribavirin + Pegylated Interferon
n=20 participants at risk
Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
|
Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon
n=10 participants at risk
Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/23 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/30 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/31 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
5.0%
1/20 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/10 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/23 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/30 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/31 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/20 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
1/10 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Hepatobiliary disorders
Hepatitis acute
|
4.3%
1/23 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/30 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/31 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/20 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/10 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Hepatobiliary disorders
Cholestatic liver injury
|
4.3%
1/23 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/30 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/31 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/20 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/10 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
Other adverse events
| Measure |
CTS-1027 60 mg + Ribavirin + Peglyated Interferon
n=23 participants at risk
Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
|
CTS-1027 30 mg + Ribavirin + Pegylated Interferon
n=30 participants at risk
Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
|
CTS-1027 15 mg + Ribavirin + Pegylated Interferon
n=31 participants at risk
Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
|
Placebo + Ribavirin + Pegylated Interferon
n=20 participants at risk
Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
|
Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon
n=10 participants at risk
Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
17.4%
4/23 • Number of events 4 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
16.7%
5/30 • Number of events 5 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
6.5%
2/31 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
5.0%
1/20 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
30.0%
3/10 • Number of events 4 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Blood and lymphatic system disorders
Neutopenia
|
8.7%
2/23 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
13.3%
4/30 • Number of events 4 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
6.5%
2/31 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
2/20 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
1/10 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Gastrointestinal disorders
Diarrhea
|
13.0%
3/23 • Number of events 5 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
13.3%
4/30 • Number of events 6 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
6.5%
2/31 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
15.0%
3/20 • Number of events 3 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
1/10 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Gastrointestinal disorders
Nausea
|
26.1%
6/23 • Number of events 8 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
30.0%
9/30 • Number of events 11 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
22.6%
7/31 • Number of events 8 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
30.0%
6/20 • Number of events 9 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
40.0%
4/10 • Number of events 5 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
General disorders
Asthenia
|
13.0%
3/23 • Number of events 3 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
6.7%
2/30 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/31 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
20.0%
4/20 • Number of events 5 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/10 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
General disorders
Chills
|
17.4%
4/23 • Number of events 5 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
16.7%
5/30 • Number of events 5 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
6.5%
2/31 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
2/20 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
20.0%
2/10 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
General disorders
Fatigue
|
65.2%
15/23 • Number of events 17 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
53.3%
16/30 • Number of events 19 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
38.7%
12/31 • Number of events 14 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
40.0%
8/20 • Number of events 8 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
60.0%
6/10 • Number of events 7 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
General disorders
Influenza like illness
|
4.3%
1/23 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
13.3%
4/30 • Number of events 5 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
12.9%
4/31 • Number of events 4 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
20.0%
4/20 • Number of events 4 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/10 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
General disorders
Injection site erythema
|
4.3%
1/23 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
6.7%
2/30 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
3.2%
1/31 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
2/20 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
1/10 • Number of events 3 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
General disorders
Injection site reaction
|
8.7%
2/23 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
3/30 • Number of events 4 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/31 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
5.0%
1/20 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/10 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
General disorders
Irritability
|
17.4%
4/23 • Number of events 5 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
20.0%
6/30 • Number of events 7 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
12.9%
4/31 • Number of events 4 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
2/20 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
1/10 • Number of events 3 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
General disorders
Pain
|
8.7%
2/23 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
6.7%
2/30 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
9.7%
3/31 • Number of events 3 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/20 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/10 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
General disorders
Pyrexia
|
8.7%
2/23 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
13.3%
4/30 • Number of events 5 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
9.7%
3/31 • Number of events 5 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
15.0%
3/20 • Number of events 4 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/10 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
General disorders
Decreased appetite
|
26.1%
6/23 • Number of events 8 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
20.0%
6/30 • Number of events 6 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
9.7%
3/31 • Number of events 3 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
2/20 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
20.0%
2/10 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
43.5%
10/23 • Number of events 15 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
43.3%
13/30 • Number of events 14 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
16.1%
5/31 • Number of events 6 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
5.0%
1/20 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
40.0%
4/10 • Number of events 10 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
2/23 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
3/30 • Number of events 4 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
3.2%
1/31 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
5.0%
1/20 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
1/10 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
26.1%
6/23 • Number of events 6 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
23.3%
7/30 • Number of events 9 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
16.1%
5/31 • Number of events 6 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
2/20 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
30.0%
3/10 • Number of events 3 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/23 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
6.7%
2/30 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
6.5%
2/31 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
2/20 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/10 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Nervous system disorders
Dizziness
|
13.0%
3/23 • Number of events 4 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
6.7%
2/30 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
12.9%
4/31 • Number of events 4 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
30.0%
6/20 • Number of events 6 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
20.0%
2/10 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Nervous system disorders
Dysgeusia
|
8.7%
2/23 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/30 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
9.7%
3/31 • Number of events 3 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
5.0%
1/20 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/10 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Nervous system disorders
Headache
|
39.1%
9/23 • Number of events 9 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
30.0%
9/30 • Number of events 9 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
38.7%
12/31 • Number of events 16 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
50.0%
10/20 • Number of events 12 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
50.0%
5/10 • Number of events 5 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Psychiatric disorders
Anxiety
|
4.3%
1/23 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
3/30 • Number of events 4 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
6.5%
2/31 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
5.0%
1/20 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/10 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Psychiatric disorders
Depression
|
0.00%
0/23 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
13.3%
4/30 • Number of events 5 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
12.9%
4/31 • Number of events 4 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
2/20 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/10 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Psychiatric disorders
Insomnia
|
17.4%
4/23 • Number of events 6 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
26.7%
8/30 • Number of events 12 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
16.1%
5/31 • Number of events 6 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
15.0%
3/20 • Number of events 3 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
40.0%
4/10 • Number of events 6 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
3/23 • Number of events 3 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
3/30 • Number of events 3 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
3.2%
1/31 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
2/20 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
20.0%
2/10 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.7%
2/23 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
6.7%
2/30 • Number of events 3 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
16.1%
5/31 • Number of events 5 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
5.0%
1/20 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
30.0%
3/10 • Number of events 3 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
13.0%
3/23 • Number of events 3 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/30 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
3.2%
1/31 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
5.0%
1/20 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
10.0%
1/10 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Hyperhirosis
|
8.7%
2/23 • Number of events 3 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
3.3%
1/30 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
6.5%
2/31 • Number of events 3 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
5.0%
1/20 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
0.00%
0/10 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.1%
6/23 • Number of events 8 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
16.7%
5/30 • Number of events 6 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
9.7%
3/31 • Number of events 3 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
5.0%
1/20 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
30.0%
3/10 • Number of events 3 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.4%
4/23 • Number of events 4 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
6.7%
2/30 • Number of events 3 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
25.8%
8/31 • Number of events 8 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
5.0%
1/20 • Number of events 1 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
20.0%
2/10 • Number of events 2 • Day 1 of dosing through 4 to 12 weeks after treatment discontinuation.
Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) to study any of the medications by the Investigator. All serious adverse events are reported regardless of causality.
|
Additional Information
MiRa Huyghe, Vice President, Clinical Development
Conatus Pharmaceuticals Inc.
Phone: (858) 457-7227
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60