Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1) (NCT NCT03422653)
NCT ID: NCT03422653
Last Updated: 2022-04-26
Results Overview
Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable". LS means estimated percent, odds ratio and P value used a logistic regression model.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
378 participants
Primary outcome timeframe
Week 12
Results posted on
2022-04-26
Participant Flow
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks.
Participant milestones
| Measure |
Double-blind CR845 0.5mcg/kg
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
CR845 0.5 mcg/kg: IV medication delivered three times/week
|
Double-blind Placebo
IV Placebo administered after each dialysis session (3 times/week)
Placebo: IV medication delivered three times/week
|
Open-label CR845 0.5 mcg/kg
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
CR845 0.5 mcg/kg: IV medication delivered three times/week
|
|---|---|---|---|
|
Period 1: Double-blind Phase
STARTED
|
189
|
189
|
0
|
|
Period 1: Double-blind Phase
COMPLETED
|
162
|
170
|
0
|
|
Period 1: Double-blind Phase
NOT COMPLETED
|
27
|
19
|
0
|
|
Period 2: Open-label Phase
STARTED
|
0
|
0
|
313
|
|
Period 2: Open-label Phase
COMPLETED
|
0
|
0
|
189
|
|
Period 2: Open-label Phase
NOT COMPLETED
|
0
|
0
|
124
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)
Baseline characteristics by cohort
| Measure |
Double-blind CR845 0.5mcg/kg
n=189 Participants
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
CR845 0.5 mcg/kg: IV medication delivered three times/week
|
Double-blind Placebo
n=189 Participants
IV Placebo administered after each dialysis session (3 times/week)
Placebo: IV medication delivered three times/week
|
Total
n=378 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 11.16 • n=5 Participants
|
56.7 years
STANDARD_DEVIATION 13.89 • n=7 Participants
|
57.5 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
82 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
91 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Data include one patient who had been randomly assigned to the placebo group and who withdrew from the trial before receiving the first dose of placebo.
Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable". LS means estimated percent, odds ratio and P value used a logistic regression model.
Outcome measures
| Measure |
CR845 0.5mcg/kg
n=189 Participants
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
CR845 0.5 mcg/kg: IV medication delivered three times/week
|
Placebo
n=189 Participants
IV Placebo administered after each dialysis session (3 times/week)
Placebo: IV medication delivered three times/week
|
|---|---|---|
|
Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12
|
51.0 percentage of subjects
Interval 42.9 to 58.9
|
27.6 percentage of subjects
Interval 20.2 to 36.6
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Data include one patient who had been randomly assigned to the placebo group and who withdrew from the trial before receiving the first dose of placebo.
The 5-D Itch Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past 2 weeks. The questions cover five dimensions of itch including the degree, duration of itch/day, direction (improvement/worsening), disability (impact on activities such as work), and body distribution of itch. The 5-D Itch Scale has 5 questions; the total 5-D Itch Scale score ranges from 5 to 25, with higher scores indicating worse responses.
Outcome measures
| Measure |
CR845 0.5mcg/kg
n=189 Participants
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
CR845 0.5 mcg/kg: IV medication delivered three times/week
|
Placebo
n=189 Participants
IV Placebo administered after each dialysis session (3 times/week)
Placebo: IV medication delivered three times/week
|
|---|---|---|
|
Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in 5-D Itch Scale Score at the End of Week 12
|
-5.0 score on a scale
Interval -5.7 to -4.4
|
-3.7 score on a scale
Interval -4.4 to -3.1
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Data include one patient who had been randomly assigned to the placebo group and who withdrew from the trial before receiving the first dose of placebo.
The Skindex-10 Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past week. The questions cover 3 domains: disease, mood/emotional distress, and social functioning domain. The Skindex-10 has 10 questions; the total Skindex-10 score ranges from 0 to 60. A lower total score represents better quality of life.
Outcome measures
| Measure |
CR845 0.5mcg/kg
n=189 Participants
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
CR845 0.5 mcg/kg: IV medication delivered three times/week
|
Placebo
n=189 Participants
IV Placebo administered after each dialysis session (3 times/week)
Placebo: IV medication delivered three times/week
|
|---|---|---|
|
Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12
|
-17.2 score on a scale
Interval -19.6 to -14.7
|
-12.0 score on a scale
Interval -14.5 to -9.6
|
SECONDARY outcome
Timeframe: Week 12Population: Data include one patient who had been randomly assigned to the placebo group and who withdrew from the trial before receiving the first dose of placebo.
Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable". LS means estimated percent, odds ratio and P value used a logistic regression model.
Outcome measures
| Measure |
CR845 0.5mcg/kg
n=189 Participants
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
CR845 0.5 mcg/kg: IV medication delivered three times/week
|
Placebo
n=189 Participants
IV Placebo administered after each dialysis session (3 times/week)
Placebo: IV medication delivered three times/week
|
|---|---|---|
|
Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥4 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score at Week 12
|
38.9 percentage of subjects
Interval 29.8 to 48.7
|
18.0 percentage of subjects
Interval 12.1 to 26.0
|
Adverse Events
Double-blind CR845 0.5mcg/kg
Serious events: 49 serious events
Other events: 40 other events
Deaths: 2 deaths
Double-blind Placebo
Serious events: 41 serious events
Other events: 30 other events
Deaths: 2 deaths
Open-label CR845 0.5 mcg/kg
Serious events: 167 serious events
Other events: 205 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Double-blind CR845 0.5mcg/kg
n=189 participants at risk
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
CR845 0.5 mcg/kg: IV medication delivered three times/week
|
Double-blind Placebo
n=188 participants at risk
IV Placebo administered after each dialysis session (3 times/week)
Placebo: IV medication delivered three times/week
|
Open-label CR845 0.5 mcg/kg
n=313 participants at risk
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
CR845 0.5 mcg/kg: IV medication delivered three times/week
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
2/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.96%
3/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Angina pectoris
|
1.1%
2/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.6%
5/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.1%
2/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
3.5%
11/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.96%
3/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.6%
5/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Angina unstable
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.9%
6/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Cardiac failure acute
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Cardiomyopathy
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Tachycardia
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
2/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.96%
3/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.9%
6/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
2/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.6%
5/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Enteritis
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Haematemesis
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.96%
3/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
General disorders
Chest pain
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.6%
3/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.96%
3/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
General disorders
Asthenia
|
1.1%
2/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
2.6%
8/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
General disorders
Complication associated with device
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
2.6%
8/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
General disorders
Gait inability
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
General disorders
Pyrexia
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
2/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Pneumonia
|
1.6%
3/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
2.7%
5/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
7.3%
23/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Sepsis
|
1.6%
3/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
2.1%
4/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
3.2%
10/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Septic shock
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.6%
3/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.9%
6/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Diverticulitis
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Abscess neck
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Bacteraemia
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.9%
6/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Clostridium difficile infection
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Endocarditis
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Gangrene
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Localised infection
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.3%
4/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Peritonitis bacterial
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.3%
4/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.96%
3/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Complications of transplanted liver
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.6%
5/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Vascular access malfunction
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.9%
6/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Investigations
Troponin increased
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.1%
2/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Investigations
Blood potassium increased
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Investigations
Transaminases increased
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.1%
4/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
2.1%
4/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
3.8%
12/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.1%
2/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
2.1%
4/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
5.1%
16/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.1%
2/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.1%
2/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.3%
4/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.1%
2/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
3.2%
10/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Nervous system disorders
Seizure
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.3%
4/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Nervous system disorders
Cerebral infarction
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Psychiatric disorders
Mental status changes
|
1.1%
2/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.1%
2/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
2.9%
9/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Psychiatric disorders
Delusional disorder, unspecified type
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Psychiatric disorders
Psychotic disorder
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Renal and urinary disorders
Azotaemia
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
General disorders
Hernia
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.6%
3/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.96%
3/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.1%
2/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
2.2%
7/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.1%
2/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.96%
3/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
3.2%
10/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.96%
3/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.3%
4/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Skin and subcutaneous tissue disorders
Ischaemic skin ulcer
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Vascular disorders
Hypotension
|
1.6%
3/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.1%
2/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
2.6%
8/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Vascular disorders
Aneurysm arteriovenous
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Vascular disorders
Hypertensive crisis
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
2.6%
8/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.96%
3/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Endocrine disorders
Hyperparathyroidism tertiary
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.96%
3/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.96%
3/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Ascities
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
2.2%
7/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
General disorders
Death
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.96%
3/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
General disorders
Hypothermia
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
General disorders
Influenza like illness
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
General disorders
Peripheral swelling
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.96%
3/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Influenza
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.96%
3/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Cystitis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Device related infection
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Eye infection
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Mastitis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Perineal cellulitis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Pyelitis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.96%
3/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site haemorrhage
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Investigations
Anticoagulation drug level below therapeutic
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Metabolism and nutrition disorders
Cacliphylaxis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Musculoskeletal and connective tissue disorders
Chronic kidney disease-mineral and bone disorder
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Nervous system disorders
Syncope
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
2.6%
8/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.3%
4/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.96%
3/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Nervous system disorders
Thoracic outlet syndrome
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Product Issues
Device occlusion
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Product Issues
Stent malfunction
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Psychiatric disorders
Confabulation
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
2/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
3.5%
11/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Social circumstances
Loss of personal independence in daily activities
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.64%
2/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Vascular disorders
Dry gangrene
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Vascular disorders
Venous occlusion
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.00%
0/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.32%
1/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
Other adverse events
| Measure |
Double-blind CR845 0.5mcg/kg
n=189 participants at risk
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
CR845 0.5 mcg/kg: IV medication delivered three times/week
|
Double-blind Placebo
n=188 participants at risk
IV Placebo administered after each dialysis session (3 times/week)
Placebo: IV medication delivered three times/week
|
Open-label CR845 0.5 mcg/kg
n=313 participants at risk
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
CR845 0.5 mcg/kg: IV medication delivered three times/week
|
|---|---|---|---|
|
General disorders
Pyrexia
|
2.6%
5/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.1%
2/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
5.4%
17/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
2/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.6%
3/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
5.1%
16/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Vascular disorders
Hypotension
|
3.7%
7/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
2.1%
4/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
15.7%
49/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
9/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
2.1%
4/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
11.5%
36/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.5%
18/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
5.3%
10/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
19.5%
61/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
6/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
7.4%
14/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
9.9%
31/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Nervous system disorders
Dizziness
|
6.9%
13/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.6%
3/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
11.2%
35/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
10/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
3.2%
6/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
13.7%
43/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
7/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
4.8%
9/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
17.3%
54/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
6/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
4.3%
8/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
16.0%
50/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Nervous system disorders
Headache
|
4.2%
8/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
2.1%
4/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
11.5%
36/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.7%
7/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.6%
3/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
11.2%
35/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.2%
6/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
4.3%
8/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
11.2%
35/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
7/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
3.7%
7/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
10.9%
34/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
6/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
2.7%
5/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
9.9%
31/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Constipation
|
3.2%
6/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
2.1%
4/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
9.3%
29/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Vascular disorders
Hypertension
|
3.7%
7/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
3.2%
6/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
8.3%
26/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
7/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
8.0%
25/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
4/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.6%
3/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
7.3%
23/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
7/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
0.53%
1/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
6.4%
20/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Psychiatric disorders
Anxiety
|
1.6%
3/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
1.1%
2/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
5.1%
16/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.53%
1/189 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
2.1%
4/188 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
5.1%
16/313 • The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
The study includes a Double-blind Phase, an Open-label Extension Phase, and a Follow-up Period. Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be eligible to receive open-label CR845 for an additional 52 weeks. Data exclude one patient randomized to placebo and who withdrew from the trial before receiving the first dose of placebo; no safety data collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place