Trial Outcomes & Findings for A POC and Dose-Ranging Study of HTD1801 in PSC Patients (NCT NCT03333928)
NCT ID: NCT03333928
Last Updated: 2025-10-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
Baseline to Week 6
Results posted on
2025-10-23
Participant Flow
Fifty-nine subjects were recruited from 23 academic medical centers and community clinics in the US and Canada. The first subject was enrolled on 18 June 2018 and the last subject last visit was completed on 10 Aug 2020.
Participant milestones
| Measure |
500mg HTD1801 BID
HTD1801: HTD1801 tablets, 250 mg
|
1000 mg HTD1801 BID
HTD1801: HTD1801 tablets, 250 mg
|
Placebo BID
Placebo: tablets manufactured to mimic HTD1801 tablets
|
|---|---|---|---|
|
Initial Dosing Period (Period 1)
STARTED
|
16
|
25
|
18
|
|
Initial Dosing Period (Period 1)
COMPLETED
|
15
|
21
|
14
|
|
Initial Dosing Period (Period 1)
NOT COMPLETED
|
1
|
4
|
4
|
|
Dose-controlled Extension (Period 2)
STARTED
|
22
|
29
|
0
|
|
Dose-controlled Extension (Period 2)
COMPLETED
|
19
|
28
|
0
|
|
Dose-controlled Extension (Period 2)
NOT COMPLETED
|
3
|
1
|
0
|
|
Randomized Withdrawal (Period 3)
STARTED
|
10
|
14
|
26
|
|
Randomized Withdrawal (Period 3)
COMPLETED
|
8
|
14
|
25
|
|
Randomized Withdrawal (Period 3)
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
500mg HTD1801 BID
HTD1801: HTD1801 tablets, 250 mg
|
1000 mg HTD1801 BID
HTD1801: HTD1801 tablets, 250 mg
|
Placebo BID
Placebo: tablets manufactured to mimic HTD1801 tablets
|
|---|---|---|---|
|
Initial Dosing Period (Period 1)
Protocol Violation
|
0
|
0
|
1
|
|
Initial Dosing Period (Period 1)
Withdrawal by Subject
|
0
|
1
|
1
|
|
Initial Dosing Period (Period 1)
Corporate decision to not initiate dosing in new patients because of COVID-19
|
1
|
0
|
1
|
|
Initial Dosing Period (Period 1)
Adverse Event
|
0
|
3
|
1
|
|
Dose-controlled Extension (Period 2)
Adverse Event
|
2
|
1
|
0
|
|
Dose-controlled Extension (Period 2)
Lost to Follow-up
|
1
|
0
|
0
|
|
Randomized Withdrawal (Period 3)
Adverse Event
|
1
|
0
|
0
|
|
Randomized Withdrawal (Period 3)
Lost to Follow-up
|
1
|
0
|
1
|
Baseline Characteristics
A POC and Dose-Ranging Study of HTD1801 in PSC Patients
Baseline characteristics by cohort
| Measure |
HTD1801 500 mg BID
n=15 Participants
HTD1801: HTD1801 tablets, 250mg
|
HTD1801 1000 mg BID
n=24 Participants
HTD1801: HTD1801 tablets, 250mg
|
Placebo BID
n=16 Participants
Placebo: tablets manufactured to mimic HTD1801 tablets
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 13.6 • n=39 Participants
|
45 years
STANDARD_DEVIATION 13.7 • n=41 Participants
|
40 years
STANDARD_DEVIATION 15.8 • n=35 Participants
|
43 years
STANDARD_DEVIATION 14.2 • n=31 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
23 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
32 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
46 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 6Population: Modified Intent-to-Treat (mITT) population: 59 subjects were randomized; however, 4 subjects did not receive the study drug. The remaining 55 subjects were dosed with study drug; however, 1 subject was excluded due to the absence of baseline assessments and withdrew due to AE on Day 2. The mITT population consisted of the remaining 54 subjects. Subjects were randomized to receive HTD1801 BID doses of 500 mg, 1000 mg, or matching placebo for 6 weeks.
Outcome measures
| Measure |
HTD1801 500 mg BID
n=15 Participants
HTD1801: HTD1801 tablets, 250 mg
|
HTD1801 1000 mg BID
n=23 Participants
HTD1801: HTD1801 tablets, 250 mg
|
Placebo BID
n=16 Participants
Placebo: tablets manufactured to mimic HTD1801 tablets
|
HTD1801 1000 mg BID to HTD1801 1000 mg BID
Subjects randomized to receive HTD1801 1000 mg BID in Period 1 continuing to receive HTD1801 1000 mg BID in Period 2
|
|---|---|---|---|---|
|
Absolute Change in Serum Alkaline Phosphatase (ALP) From Baseline to Week 6 in Period 1
|
-71 U/L
Standard Error 136.9
|
-73 U/L
Standard Error 139.9
|
94 U/L
Standard Error 261.7
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Period 1 mITT population: 54 subjects.
Outcome measures
| Measure |
HTD1801 500 mg BID
n=15 Participants
HTD1801: HTD1801 tablets, 250 mg
|
HTD1801 1000 mg BID
n=23 Participants
HTD1801: HTD1801 tablets, 250 mg
|
Placebo BID
n=16 Participants
Placebo: tablets manufactured to mimic HTD1801 tablets
|
HTD1801 1000 mg BID to HTD1801 1000 mg BID
Subjects randomized to receive HTD1801 1000 mg BID in Period 1 continuing to receive HTD1801 1000 mg BID in Period 2
|
|---|---|---|---|---|
|
Percentage of Subjects Who Achieve ALP of <1.5 x ULN at the End of Week 6 (Period 1)
|
2 Participants
|
6 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Period 1 mITT population: 54 subjects.
Outcome measures
| Measure |
HTD1801 500 mg BID
n=15 Participants
HTD1801: HTD1801 tablets, 250 mg
|
HTD1801 1000 mg BID
n=23 Participants
HTD1801: HTD1801 tablets, 250 mg
|
Placebo BID
n=16 Participants
Placebo: tablets manufactured to mimic HTD1801 tablets
|
HTD1801 1000 mg BID to HTD1801 1000 mg BID
Subjects randomized to receive HTD1801 1000 mg BID in Period 1 continuing to receive HTD1801 1000 mg BID in Period 2
|
|---|---|---|---|---|
|
Percentage of Subjects Who Achieve a 50% Decrease in ALP at the End of Week 6 (Period 1)
|
1 Participants
|
4 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Period 1 mITT population: 54 subjects.
Outcome measures
| Measure |
HTD1801 500 mg BID
n=15 Participants
HTD1801: HTD1801 tablets, 250 mg
|
HTD1801 1000 mg BID
n=23 Participants
HTD1801: HTD1801 tablets, 250 mg
|
Placebo BID
n=16 Participants
Placebo: tablets manufactured to mimic HTD1801 tablets
|
HTD1801 1000 mg BID to HTD1801 1000 mg BID
Subjects randomized to receive HTD1801 1000 mg BID in Period 1 continuing to receive HTD1801 1000 mg BID in Period 2
|
|---|---|---|---|---|
|
Percentage of Subjects Who Normalize ALP at the End of Week 6 (Period 1)
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Period 1 mITT population: 54 subjects.
Outcome measures
| Measure |
HTD1801 500 mg BID
n=15 Participants
HTD1801: HTD1801 tablets, 250 mg
|
HTD1801 1000 mg BID
n=23 Participants
HTD1801: HTD1801 tablets, 250 mg
|
Placebo BID
n=15 Participants
Placebo: tablets manufactured to mimic HTD1801 tablets
|
HTD1801 1000 mg BID to HTD1801 1000 mg BID
Subjects randomized to receive HTD1801 1000 mg BID in Period 1 continuing to receive HTD1801 1000 mg BID in Period 2
|
|---|---|---|---|---|
|
Absolute Change in Serum Total Bilirubin at the End of Week 6 (Period 1)
|
-0.2 mg/dL
Standard Deviation 0.52
|
0.0 mg/dL
Standard Deviation 0.50
|
0.1 mg/dL
Standard Deviation 0.26
|
—
|
SECONDARY outcome
Timeframe: Week 6 to Week 12Population: Subjects previously randomized in Period 1 to HTD1801 500 mg BID or HTD1801 1000 mg BID continued for 6 more weeks at that previous dose, while subjects previously randomized to placebo were re-randomized to receive 6 weeks of either HTD1801 500 mg BID or HTD1801 1000 mg BID. 51 subjects in the mITT population started Period 2. 49 subjects in the mITT population completed Period 2.
Outcome measures
| Measure |
HTD1801 500 mg BID
n=7 Participants
HTD1801: HTD1801 tablets, 250 mg
|
HTD1801 1000 mg BID
n=14 Participants
HTD1801: HTD1801 tablets, 250 mg
|
Placebo BID
n=7 Participants
Placebo: tablets manufactured to mimic HTD1801 tablets
|
HTD1801 1000 mg BID to HTD1801 1000 mg BID
n=21 Participants
Subjects randomized to receive HTD1801 1000 mg BID in Period 1 continuing to receive HTD1801 1000 mg BID in Period 2
|
|---|---|---|---|---|
|
Absolute Change in Serum ALP From Week 6 to Week 12 (Period 2)
|
-34 U/L
Standard Deviation 180.3
|
-14 U/L
Standard Deviation 74.6
|
-189 U/L
Standard Deviation 270.7
|
10 U/L
Standard Deviation 65.9
|
SECONDARY outcome
Timeframe: Week 6 to Week 12Population: 51 subjects in the mITT population who completed Period 1 and began Period 2.
Outcome measures
| Measure |
HTD1801 500 mg BID
n=7 Participants
HTD1801: HTD1801 tablets, 250 mg
|
HTD1801 1000 mg BID
n=15 Participants
HTD1801: HTD1801 tablets, 250 mg
|
Placebo BID
n=7 Participants
Placebo: tablets manufactured to mimic HTD1801 tablets
|
HTD1801 1000 mg BID to HTD1801 1000 mg BID
n=22 Participants
Subjects randomized to receive HTD1801 1000 mg BID in Period 1 continuing to receive HTD1801 1000 mg BID in Period 2
|
|---|---|---|---|---|
|
Percentage of Subjects Who Achieve ALP of <1.5 x ULN at the End of Week 12 (Period 2)
|
0 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 6 to Week 12Population: 51 subjects in the mITT population who completed Period 1 and began Period 2.
Outcome measures
| Measure |
HTD1801 500 mg BID
n=7 Participants
HTD1801: HTD1801 tablets, 250 mg
|
HTD1801 1000 mg BID
n=15 Participants
HTD1801: HTD1801 tablets, 250 mg
|
Placebo BID
n=7 Participants
Placebo: tablets manufactured to mimic HTD1801 tablets
|
HTD1801 1000 mg BID to HTD1801 1000 mg BID
n=22 Participants
Subjects randomized to receive HTD1801 1000 mg BID in Period 1 continuing to receive HTD1801 1000 mg BID in Period 2
|
|---|---|---|---|---|
|
Percentage of Patients Who Achieve a 50% Decrease in ALP at the End of Week 12 (Period 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 6 to Week 12Population: 51 subjects in the mITT population who completed Period 1 and began Period 2.
Outcome measures
| Measure |
HTD1801 500 mg BID
n=7 Participants
HTD1801: HTD1801 tablets, 250 mg
|
HTD1801 1000 mg BID
n=15 Participants
HTD1801: HTD1801 tablets, 250 mg
|
Placebo BID
n=7 Participants
Placebo: tablets manufactured to mimic HTD1801 tablets
|
HTD1801 1000 mg BID to HTD1801 1000 mg BID
n=22 Participants
Subjects randomized to receive HTD1801 1000 mg BID in Period 1 continuing to receive HTD1801 1000 mg BID in Period 2
|
|---|---|---|---|---|
|
Percentage of Patients Who Normalize ALP at the End of Week 12 (Period 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 6 to Week 12Population: 49 subjects in the mITT population who completed Period 2.
Outcome measures
| Measure |
HTD1801 500 mg BID
n=7 Participants
HTD1801: HTD1801 tablets, 250 mg
|
HTD1801 1000 mg BID
n=14 Participants
HTD1801: HTD1801 tablets, 250 mg
|
Placebo BID
n=7 Participants
Placebo: tablets manufactured to mimic HTD1801 tablets
|
HTD1801 1000 mg BID to HTD1801 1000 mg BID
n=21 Participants
Subjects randomized to receive HTD1801 1000 mg BID in Period 1 continuing to receive HTD1801 1000 mg BID in Period 2
|
|---|---|---|---|---|
|
Absolute Change in Serum Total Bilirubin at the End of Week 12 (Period 2)
|
-0.1 mg/dL
Standard Deviation 0.28
|
0.0 mg/dL
Standard Deviation 0.25
|
-0.4 mg/dL
Standard Deviation 0.16
|
0.0 mg/dL
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Week 12 to Week 18Population: All subjects were re-randomized to either continue on the active treatment they received in Period 2 or be assigned to placebo. 50 subjects in the mITT population started Period 3. 49 subjects in the mITT population completed Period 3.
Change in serum ALP between a new baseline at Week 12 and the final value at Week 18 for all subjects following the randomized withdrawal
Outcome measures
| Measure |
HTD1801 500 mg BID
n=9 Participants
HTD1801: HTD1801 tablets, 250 mg
|
HTD1801 1000 mg BID
n=14 Participants
HTD1801: HTD1801 tablets, 250 mg
|
Placebo BID
n=12 Participants
Placebo: tablets manufactured to mimic HTD1801 tablets
|
HTD1801 1000 mg BID to HTD1801 1000 mg BID
n=14 Participants
Subjects randomized to receive HTD1801 1000 mg BID in Period 1 continuing to receive HTD1801 1000 mg BID in Period 2
|
|---|---|---|---|---|
|
Absolute Change in Serum ALP From Week 12 to Week 18 (Period 3)
|
-63 U/L
Standard Deviation 88.9
|
21 U/L
Standard Deviation 141.7
|
183 U/L
Standard Deviation 292.0
|
142 U/L
Standard Deviation 163.7
|
SECONDARY outcome
Timeframe: Week 12 to Week 18Population: 50 subjects in the mITT population who completed Period 2 and began Period 3.
The percentage of patients who achieve ALP of \<1.5 x ULN at the end of week 18 (Period 3)
Outcome measures
| Measure |
HTD1801 500 mg BID
n=10 Participants
HTD1801: HTD1801 tablets, 250 mg
|
HTD1801 1000 mg BID
n=14 Participants
HTD1801: HTD1801 tablets, 250 mg
|
Placebo BID
n=12 Participants
Placebo: tablets manufactured to mimic HTD1801 tablets
|
HTD1801 1000 mg BID to HTD1801 1000 mg BID
n=14 Participants
Subjects randomized to receive HTD1801 1000 mg BID in Period 1 continuing to receive HTD1801 1000 mg BID in Period 2
|
|---|---|---|---|---|
|
Percentage of Patients Who Achieve ALP of <1.5 x ULN at the End of Week 18 (Period 3)
|
1 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 12 to Week 18Population: 50 subjects in the mITT population who completed Period 2 and began Period 3.
Outcome measures
| Measure |
HTD1801 500 mg BID
n=10 Participants
HTD1801: HTD1801 tablets, 250 mg
|
HTD1801 1000 mg BID
n=14 Participants
HTD1801: HTD1801 tablets, 250 mg
|
Placebo BID
n=12 Participants
Placebo: tablets manufactured to mimic HTD1801 tablets
|
HTD1801 1000 mg BID to HTD1801 1000 mg BID
n=14 Participants
Subjects randomized to receive HTD1801 1000 mg BID in Period 1 continuing to receive HTD1801 1000 mg BID in Period 2
|
|---|---|---|---|---|
|
Percentage of Patients Who Achieve a 50% Decrease in ALP at the End of Week 18 (Period 3)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 12 to Week 18Population: 50 subjects in the mITT population who completed Period 2 and began Period 3.
Outcome measures
| Measure |
HTD1801 500 mg BID
n=10 Participants
HTD1801: HTD1801 tablets, 250 mg
|
HTD1801 1000 mg BID
n=14 Participants
HTD1801: HTD1801 tablets, 250 mg
|
Placebo BID
n=12 Participants
Placebo: tablets manufactured to mimic HTD1801 tablets
|
HTD1801 1000 mg BID to HTD1801 1000 mg BID
n=14 Participants
Subjects randomized to receive HTD1801 1000 mg BID in Period 1 continuing to receive HTD1801 1000 mg BID in Period 2
|
|---|---|---|---|---|
|
Percentage of Subjects Who Normalize ALP at the End of Week 18 (Period 3)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 12 to Week 18Population: 49 subjects in the mITT population who completed Period 3.
Outcome measures
| Measure |
HTD1801 500 mg BID
n=9 Participants
HTD1801: HTD1801 tablets, 250 mg
|
HTD1801 1000 mg BID
n=14 Participants
HTD1801: HTD1801 tablets, 250 mg
|
Placebo BID
n=12 Participants
Placebo: tablets manufactured to mimic HTD1801 tablets
|
HTD1801 1000 mg BID to HTD1801 1000 mg BID
n=14 Participants
Subjects randomized to receive HTD1801 1000 mg BID in Period 1 continuing to receive HTD1801 1000 mg BID in Period 2
|
|---|---|---|---|---|
|
Absolute Change in Serum Total Bilirubin at the End of Week 18 (Period 3)
|
-0.2 mg/dL
Standard Deviation 0.19
|
0.0 mg/dL
Standard Deviation 0.23
|
0.1 mg/dL
Standard Deviation 0.36
|
0.1 mg/dL
Standard Deviation 0.22
|
Adverse Events
500mg HTD1801 bid
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
1000mg HTD1801 bid
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
placebo bid
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
500mg HTD1801 bid
n=22 participants at risk
HTD1801: HTD1801 tablets, 250mg
|
1000mg HTD1801 bid
n=31 participants at risk
HTD1801: HTD1801 tablets, 250mg
|
placebo bid
n=35 participants at risk
Placebo: tablets manufactured to mimic HTD1801 tablets
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Joint Injury
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
Other adverse events
| Measure |
500mg HTD1801 bid
n=22 participants at risk
HTD1801: HTD1801 tablets, 250mg
|
1000mg HTD1801 bid
n=31 participants at risk
HTD1801: HTD1801 tablets, 250mg
|
placebo bid
n=35 participants at risk
Placebo: tablets manufactured to mimic HTD1801 tablets
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
22.6%
7/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
12.9%
4/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
6.5%
2/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Inflammatory Bowel Disease
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
9.7%
3/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
5.7%
2/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Upper Respiratory Tract Infection
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
6.5%
2/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Sinusitis
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Bronchitis
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Clostridium Difficile Colitis
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Cystitis
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Influenza
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Laryngitis
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Localised Infection
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Oral Herpes
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Gastrointestinal disorders
Tonsillitis
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
2/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
16.1%
5/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
5.7%
2/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
6.5%
2/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Skin and subcutaneous tissue disorders
Hair Texture Abnormal
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Skin and subcutaneous tissue disorders
Spider Naevus
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
14.3%
5/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
8.6%
3/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
8.6%
3/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
8.6%
3/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Investigations
Liver Function Test Increased
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
8.6%
3/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Investigations
Blood Potassium Decreased
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
General disorders
Pyrexia
|
9.1%
2/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
6.5%
2/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
General disorders
Influenza Like Illness
|
9.1%
2/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
General disorders
Fatigue
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
General disorders
Chest Pain
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
General disorders
Chills
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
6.5%
2/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Nervous system disorders
Dizziness
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Nervous system disorders
Cervical Radiculopathy
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Nervous system disorders
Lumbar Radiculopathy
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Nervous system disorders
Migraine
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
6.5%
2/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum Increased
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
6.5%
2/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Injury, poisoning and procedural complications
Spinal Column Injury
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Injury, poisoning and procedural complications
Stoma Site Haemorrhage
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Vascular disorders
Hot Flush
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Vascular disorders
Hypotension
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Hepatobiliary disorders
Cholangitis
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic Naevus
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.5%
1/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
2.9%
1/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/22 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
3.2%
1/31 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
0.00%
0/35 • Adverse events were collected from the time the subject signed the informed consent form at the screening date through Study Visit Week 22.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60