Trial Outcomes & Findings for A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic Osteoarthritis (OA) Pain (NCT NCT00631319)
NCT ID: NCT00631319
Last Updated: 2020-09-16
Results Overview
Participants rate their pain intensity on a numeric rating scale (NRS), where 0=no pain and 10=worst possible pain, in a daily diary. At Week 12 (or final visit), all measurements during the preceding week are averaged, and the mean change from the mean score at baseline is calculated.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
343 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2020-09-16
Participant Flow
Participant milestones
| Measure |
OROS Hydromorphone
OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg
|
Placebo
Matching placebo tablets orally once daily
|
|---|---|---|
|
Conversion and Titration Phase
STARTED
|
343
|
0
|
|
Conversion and Titration Phase
COMPLETED
|
200
|
0
|
|
Conversion and Titration Phase
NOT COMPLETED
|
143
|
0
|
|
Double-blind Phase
STARTED
|
100
|
100
|
|
Double-blind Phase
COMPLETED
|
60
|
65
|
|
Double-blind Phase
NOT COMPLETED
|
40
|
35
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
OROS Hydromorphone
n=100 Participants
OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg
|
Placebo
n=100 Participants
Matching placebo tablets orally once daily
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=200 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
83 Participants
n=100 Participants
|
77 Participants
n=100 Participants
|
160 Participants
n=200 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=100 Participants
|
23 Participants
n=100 Participants
|
40 Participants
n=200 Participants
|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 9.78 • n=100 Participants
|
55.4 years
STANDARD_DEVIATION 11.1 • n=100 Participants
|
55.8 years
STANDARD_DEVIATION 10.44 • n=200 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=100 Participants
|
53 Participants
n=100 Participants
|
107 Participants
n=200 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=100 Participants
|
47 Participants
n=100 Participants
|
93 Participants
n=200 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
100 participants
n=100 Participants
|
100 participants
n=100 Participants
|
200 participants
n=200 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Intent to treat population defined as all patients randomized to the Double-blind phase who received at least one dose of randomized study medication.
Participants rate their pain intensity on a numeric rating scale (NRS), where 0=no pain and 10=worst possible pain, in a daily diary. At Week 12 (or final visit), all measurements during the preceding week are averaged, and the mean change from the mean score at baseline is calculated.
Outcome measures
| Measure |
OROS Hydromorphone
n=100 Participants
OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64
|
Placebo
n=100 Participants
Matching placebo tablets orally once daily
|
|---|---|---|
|
Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity Change From Baseline to Week 12 or Final Visit of the Double-blind Phase
|
0.6 units on a scale
Standard Deviation 2.02
|
0.6 units on a scale
Standard Deviation 1.87
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 12Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 12Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 12Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 12Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 12Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: within 12 weeks from BaselineOutcome measures
Outcome data not reported
Adverse Events
Conversion and Titration Phase
Serious events: 6 serious events
Other events: 197 other events
Deaths: 0 deaths
Double-blind Phase - Hydromorphone
Serious events: 5 serious events
Other events: 68 other events
Deaths: 0 deaths
Double-blind Phase - Placebo
Serious events: 1 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Conversion and Titration Phase
n=338 participants at risk
OROS hydromorphone 12, 16, 24, 32, 40, 48 or 64 mg
|
Double-blind Phase - Hydromorphone
n=100 participants at risk
OROS hydromorphone 12, 16, 24, 32, 40, 48 or 64 mg
|
Double-blind Phase - Placebo
n=100 participants at risk
Matching placebo tablets orally once daily
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.30%
1/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
1.0%
1/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
1.0%
1/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.30%
1/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
1.0%
1/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
General disorders
Oedema peripheral
|
0.30%
1/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.30%
1/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Infections and infestations
Pneumonia
|
0.30%
1/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
1.0%
1/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Infections and infestations
Septic shock
|
0.30%
1/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
1.0%
1/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.30%
1/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
1.0%
1/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Psychiatric disorders
Completed suicide
|
0.30%
1/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Renal and urinary disorders
Urethral caruncle
|
0.30%
1/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Vascular disorders
Embolism
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
1.0%
1/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
Other adverse events
| Measure |
Conversion and Titration Phase
n=338 participants at risk
OROS hydromorphone 12, 16, 24, 32, 40, 48 or 64 mg
|
Double-blind Phase - Hydromorphone
n=100 participants at risk
OROS hydromorphone 12, 16, 24, 32, 40, 48 or 64 mg
|
Double-blind Phase - Placebo
n=100 participants at risk
Matching placebo tablets orally once daily
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
7.0%
7/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
1.0%
1/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Gastrointestinal disorders
Constipation
|
17.5%
59/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
20.0%
20/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
4.0%
4/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
6.0%
6/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
7.0%
7/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Gastrointestinal disorders
Nausea
|
15.7%
53/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
14.0%
14/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
5.0%
5/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
19/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
9.0%
9/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
5.0%
5/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
General disorders
Drug withdrawal syndrome
|
4.4%
15/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
5.0%
5/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
8.0%
8/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
General disorders
Fatigue
|
3.3%
11/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
1.0%
1/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
General disorders
Oedema peripheral
|
3.0%
10/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
4.0%
4/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
1.0%
1/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
General disorders
Pyrexia
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
3.0%
3/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
3.0%
3/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
4.0%
4/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Infections and infestations
Influenza
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
3.0%
3/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
4.0%
4/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Infections and infestations
Sinusitis
|
2.7%
9/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
3.0%
3/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
3.0%
3/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
7/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
4.0%
4/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
3.0%
3/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
3.0%
3/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
1.0%
1/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Investigations
Weight decreased
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
3.0%
3/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Metabolism and nutrition disorders
Arthralgia
|
2.1%
7/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
7.0%
7/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
3.0%
3/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
9/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.89%
3/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
1.0%
1/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Nervous system disorders
Dizziness
|
4.4%
15/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
4.0%
4/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Nervous system disorders
Headache
|
6.5%
22/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
5.0%
5/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
7.0%
7/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Nervous system disorders
Somnolence
|
8.3%
28/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
1.0%
1/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Nervous system disorders
Tremor
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
3.0%
3/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
1.0%
1/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
0.00%
0/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
3.0%
3/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
1.0%
1/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.4%
8/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
2.0%
2/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
1.0%
1/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
11/338 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
3.0%
3/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
1.0%
1/100 • Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place