Trial Outcomes & Findings for Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises (NCT NCT01895361)
NCT ID: NCT01895361
Last Updated: 2020-01-31
Results Overview
An SCPC is defined as an acute episode of pain with no other medically determined cause than a vasoocclusive event that requires a medical facility visit and treatment with oral or parenteral narcotics, or parenteral non-steroidal anti-inflammatory drugs. The annual rate of SCPC is defined as the total number of pain crises for a patient occurring from the date of randomization to the end date multiplied by 365 divided by the number of days during that same time period. End date is defined as the last dose date plus 14 days. For participants never dosed, the end date was the end of study date. This calculation accounts for early dropouts or lost to follow-up by extrapolating the SCPC rate of every participant to one year.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
198 participants
Primary outcome timeframe
One year
Results posted on
2020-01-31
Participant Flow
Approx. 174 patients were planned. A total of 198 patients were randomized. 192 patients received at least 1 dose of study drug \& were analyzed for safety; 198 patients were analyzed for efficacy, 125 patients contributed data to the analysis of SelG1 PK data, \& 176 patients contributed data to the analysis of PD data (% P-selectin inhibition).
The study included a Screening Phase, Treatment Phase, and Follow-up Evaluation Phase. During the Screening Phase, potential study participants were to be fully screened for both inclusion and exclusion criteria before and undergo clinical and laboratory evaluations within 30 days prior to randomization into the study.
Participant milestones
| Measure |
High-dose SelG1 (Selg1 5.0 mg/kg)
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Low-dose SelG1 (Selg1 2.5 mg/kg)
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Placebo
IV Infusion, once every 4 weeks through Week 50
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
67
|
66
|
65
|
|
Overall Study
COMPLETED
|
43
|
45
|
41
|
|
Overall Study
NOT COMPLETED
|
24
|
21
|
24
|
Reasons for withdrawal
| Measure |
High-dose SelG1 (Selg1 5.0 mg/kg)
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Low-dose SelG1 (Selg1 2.5 mg/kg)
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Placebo
IV Infusion, once every 4 weeks through Week 50
Placebo
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
3
|
|
Overall Study
Death
|
2
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
6
|
|
Overall Study
Non-compliance with study
|
1
|
3
|
1
|
|
Overall Study
Physician Decision
|
2
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
6
|
6
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
|
Overall Study
Reasons different from categories above
|
7
|
3
|
4
|
Baseline Characteristics
Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises
Baseline characteristics by cohort
| Measure |
High-dose SelG1 (Selg1 5.0 mg/kg)
n=67 Participants
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Low-dose SelG1 (Selg1 2.5 mg/kg)
n=66 Participants
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Placebo
n=65 Participants
IV Infusion, once every 4 weeks through Week 50
Placebo
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
30.9 years
STANDARD_DEVIATION 10.89 • n=5 Participants
|
30.1 years
STANDARD_DEVIATION 9.79 • n=7 Participants
|
29.3 years
STANDARD_DEVIATION 10.36 • n=5 Participants
|
30.1 years
STANDARD_DEVIATION 10.33 • n=4 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
60 participants
n=5 Participants
|
62 participants
n=7 Participants
|
60 participants
n=5 Participants
|
182 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: Intent-to-Treat (ITT) population: The ITT population includes all randomized participants.
An SCPC is defined as an acute episode of pain with no other medically determined cause than a vasoocclusive event that requires a medical facility visit and treatment with oral or parenteral narcotics, or parenteral non-steroidal anti-inflammatory drugs. The annual rate of SCPC is defined as the total number of pain crises for a patient occurring from the date of randomization to the end date multiplied by 365 divided by the number of days during that same time period. End date is defined as the last dose date plus 14 days. For participants never dosed, the end date was the end of study date. This calculation accounts for early dropouts or lost to follow-up by extrapolating the SCPC rate of every participant to one year.
Outcome measures
| Measure |
High-dose SelG1 (Selg1 5.0 mg/kg)
n=67 Participants
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Low-dose SelG1 (Selg1 2.5 mg/kg)
n=66 Participants
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Placebo
n=65 Participants
IV Infusion, once every 4 weeks through Week 50
Placebo
|
|---|---|---|---|
|
Annual Rate of Sickle Cell-related Pain Crises (SCPC) Per Hodges-Lehmann Median
|
1.63 SCPC per year
Interval 0.0 to 24.3
|
2.01 SCPC per year
Interval 0.0 to 24.3
|
2.98 SCPC per year
Interval 0.0 to 24.3
|
PRIMARY outcome
Timeframe: One yearPopulation: Intent-to-Treat (ITT) population: The ITT population includes all randomized participants.
An SCPC is defined as an acute episode of pain with no other medically determined cause than a vasoocclusive event that requires a medical facility visit and treatment with oral or parenteral narcotics, or parenteral non-steroidal anti-inflammatory drugs. The annual rate of SCPC is defined as the total number of pain crises for a patient occurring from the date of randomization to the end date multiplied by 365 divided by the number of days during that same time period. End date is defined as the last dose date plus 14 days. For participants never dosed, the end date was the end of study date. This calculation accounts for early dropouts or lost to follow-up by extrapolating the SCPC rate of every participant to one year.
Outcome measures
| Measure |
High-dose SelG1 (Selg1 5.0 mg/kg)
n=67 Participants
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Low-dose SelG1 (Selg1 2.5 mg/kg)
n=66 Participants
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Placebo
n=65 Participants
IV Infusion, once every 4 weeks through Week 50
Placebo
|
|---|---|---|---|
|
Annual Rate of Sickle Cell-related Pain Crises (SCPC) - Per Standard Median
|
1.63 SCPC per year
Interval 0.0 to 24.3
|
2.01 SCPC per year
Interval 0.0 to 24.3
|
2.98 SCPC per year
Interval 0.0 to 24.3
|
SECONDARY outcome
Timeframe: One yearPopulation: ITT: The ITT population includes all randomized patients.
The annual rate of days hospitalized was calculated as the number of days hospitalized multiplied by 365 divided by the end date minus the date of randomization plus one where the end date is defined as the last dose date plus 14 days (for subjects never dosed, the end date equaled the end of study date, which was the last site contact for these patients).
Outcome measures
| Measure |
High-dose SelG1 (Selg1 5.0 mg/kg)
n=67 Participants
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Low-dose SelG1 (Selg1 2.5 mg/kg)
n=66 Participants
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Placebo
n=65 Participants
IV Infusion, once every 4 weeks through Week 50
Placebo
|
|---|---|---|---|
|
Annual Rate of Days Hospitalized (Key Secondary Endpoint) Per Hodges-Lehmann Median
|
4.00 Days hospitalized per year
Interval 0.0 to 130.7
|
6.87 Days hospitalized per year
Interval 0.0 to 151.0
|
6.87 Days hospitalized per year
Interval 0.0 to 307.4
|
SECONDARY outcome
Timeframe: Up to one yearPopulation: ITT population: The ITT population includes all randomized participants.
Time to first SCPC is defined as months from randomization to first SCPC. A participant without SCPC before withdrawal or completion of the study is considered censored at the time of the end date. End date is defined as the last dose plus 14 days. For participants never dosed, the end date is the end of study date.
Outcome measures
| Measure |
High-dose SelG1 (Selg1 5.0 mg/kg)
n=67 Participants
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Low-dose SelG1 (Selg1 2.5 mg/kg)
n=66 Participants
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Placebo
n=65 Participants
IV Infusion, once every 4 weeks through Week 50
Placebo
|
|---|---|---|---|
|
Time to First Sickle Cell-related Pain Crisis
|
4.07 months
Interval 1.31 to
NA = insufficient number of participants with events
|
2.20 months
Interval 0.95 to 6.6
|
1.38 months
Interval 0.39 to 4.9
|
SECONDARY outcome
Timeframe: Up to one yearPopulation: ITT population: The ITT population includes all randomized participants.
Time to second SCPC is defined as months from randomization to second SCPC. A patient with less than two SCPC before withdrawal or completion of the study is considered censored at the time of the end date. End date is defined as the last dose plus 14 days. For patients never dosed, the end date is the end of study date.
Outcome measures
| Measure |
High-dose SelG1 (Selg1 5.0 mg/kg)
n=67 Participants
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Low-dose SelG1 (Selg1 2.5 mg/kg)
n=66 Participants
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Placebo
n=65 Participants
IV Infusion, once every 4 weeks through Week 50
Placebo
|
|---|---|---|---|
|
Time to Second Sickle Cell-related Pain Crisis
|
10.32 months
Interval 4.47 to
NA = insufficient number of participants with events
|
9.20 months
Interval 3.94 to 12.16
|
5.09 months
Interval 2.96 to 11.01
|
SECONDARY outcome
Timeframe: Up to one yearPopulation: ITT population: The ITT population includes all randomized participants.
Uncomplicated SCPC is defined as an acute episode of pain with no known cause for pain other than a vasoocclusive event; requiring a visit to a medical facility; and requiring treatment with a parenteral or oral narcotic (including opiates), or parenteral NSAIDs; but is NOT classified as an acute chest syndrome, hepatic sequestration, splenic sequestration or priapism.
Outcome measures
| Measure |
High-dose SelG1 (Selg1 5.0 mg/kg)
n=67 Participants
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Low-dose SelG1 (Selg1 2.5 mg/kg)
n=66 Participants
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Placebo
n=65 Participants
IV Infusion, once every 4 weeks through Week 50
Placebo
|
|---|---|---|---|
|
Annual Rate of Uncomplicated Sickle Cell-related Pain Crisis Per Hodges-Lehmann Median
|
1.08 Uncomplicated SCPC per year
Interval 0.0 to 24.3
|
2.00 Uncomplicated SCPC per year
Interval 0.0 to 24.3
|
2.91 Uncomplicated SCPC per year
Interval 0.0 to 19.2
|
SECONDARY outcome
Timeframe: One yearPopulation: ITT population: The ITT population includes all randomized participants.
Acute Chest Syndrome (ACS) is defined on the basis of the finding of a new pulmonary infiltrate involving at least one complete lung segment that was consistent with alveolar consolidation, but excluding atelectasis (as indicated by chest X-ray). At least one of the following additional signs or symptoms needs to be present as well: a participant had to have reported chest pain, a temperature of more than 38.5oC, tachypnea, wheezing or cough.
Outcome measures
| Measure |
High-dose SelG1 (Selg1 5.0 mg/kg)
n=67 Participants
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Low-dose SelG1 (Selg1 2.5 mg/kg)
n=66 Participants
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Placebo
n=65 Participants
IV Infusion, once every 4 weeks through Week 50
Placebo
|
|---|---|---|---|
|
Annual Rate of Acute Chest Syndrome Per Hodges-Lehmann Median
|
0.00 accute chest syndrome per year
Interval 0.0 to 3.7
|
0.00 accute chest syndrome per year
Interval 0.0 to 3.9
|
0.00 accute chest syndrome per year
Interval 0.0 to 24.3
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Week 14, Week 26, Week 38, Week 52, and Week 58, up to 58 weeksPopulation: ITT population: The ITT population includes all randomized participants.
The BPI instrument was completed by the patients at pre-specified study visits prior to \& during the Treatment \& Follow-Up Evaluation Phases. Patients completed the brief pain inventory long-form, 1-week recall at the indicated pre-specified study visits. The BPI is a standardized self-reported questionnaire developed to provide information on the intensity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI also asks questions about pain relief, pain quality, \& the patient's perception of the cause of pain. Since pain can be quite variable over a day, the BPI asks patients to rate their pain at the time of responding to the questionnaire (pain now), \& also at its worst, least, \& average over the previous week. The scorings for pain \& interference have a range from 0 (no pain/no interference) to 10 (worst pain/complete interference). The BPI scoring manual was used to calculate scores for each domain.
Outcome measures
| Measure |
High-dose SelG1 (Selg1 5.0 mg/kg)
n=67 Participants
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Low-dose SelG1 (Selg1 2.5 mg/kg)
n=66 Participants
IV Infusion, once every 4 weeks through Week 50
SelG1
|
Placebo
n=65 Participants
IV Infusion, once every 4 weeks through Week 50
Placebo
|
|---|---|---|---|
|
Patient Reported Outcome: Change From Baseline in Pain Severity/Pain Interference Domain From Brief Pain Inventory (BPI) Questionnaire
Pain Severity: Baseline (BL) (n=48,49,55)
|
4.363 score on a scale
Standard Deviation 2.1176
|
4.531 score on a scale
Standard Deviation 2.0089
|
4.129 score on a scale
Standard Deviation 2.0076
|
|
Patient Reported Outcome: Change From Baseline in Pain Severity/Pain Interference Domain From Brief Pain Inventory (BPI) Questionnaire
Pain Severity: CFB to Day 15 (n=38,42,47)
|
-0.123 score on a scale
Standard Deviation 1.3419
|
0.073 score on a scale
Standard Deviation 1.5097
|
0.355 score on a scale
Standard Deviation 1.7289
|
|
Patient Reported Outcome: Change From Baseline in Pain Severity/Pain Interference Domain From Brief Pain Inventory (BPI) Questionnaire
Pain Severity: CFB to Week (Wk) 14 (n=32,33,33)
|
-0.146 score on a scale
Standard Deviation 1.1520
|
-0.068 score on a scale
Standard Deviation 1.4608
|
-0.152 score on a scale
Standard Deviation 2.0918
|
|
Patient Reported Outcome: Change From Baseline in Pain Severity/Pain Interference Domain From Brief Pain Inventory (BPI) Questionnaire
Pain Severity: CFB to Week 26 (n=27,31,32)
|
-0.377 score on a scale
Standard Deviation 1.2460
|
-0.290 score on a scale
Standard Deviation 1.9865
|
-0.563 score on a scale
Standard Deviation 2.3751
|
|
Patient Reported Outcome: Change From Baseline in Pain Severity/Pain Interference Domain From Brief Pain Inventory (BPI) Questionnaire
Pain Severity: CFB to Week 38 (n=25,29,29)
|
-0.267 score on a scale
Standard Deviation 1.4079
|
0.026 score on a scale
Standard Deviation 1.3893
|
0.333 score on a scale
Standard Deviation 1.8430
|
|
Patient Reported Outcome: Change From Baseline in Pain Severity/Pain Interference Domain From Brief Pain Inventory (BPI) Questionnaire
Pain Severity: CFB to Week 52 (n=18,23,22)
|
-0.634 score on a scale
Standard Deviation 1.8501
|
0.130 score on a scale
Standard Deviation 1.5899
|
-0.310 score on a scale
Standard Deviation 1.9508
|
|
Patient Reported Outcome: Change From Baseline in Pain Severity/Pain Interference Domain From Brief Pain Inventory (BPI) Questionnaire
Pain Severity: CFB to Wk 58 follow up (n=27,33,30)
|
-0.145 score on a scale
Standard Deviation 1.2309
|
0.091 score on a scale
Standard Deviation 1.3790
|
-0.444 score on a scale
Standard Deviation 1.8626
|
|
Patient Reported Outcome: Change From Baseline in Pain Severity/Pain Interference Domain From Brief Pain Inventory (BPI) Questionnaire
Pain Interference: BL (n=48,49,55)
|
4.643 score on a scale
Standard Deviation 2.5726
|
4.656 score on a scale
Standard Deviation 2.6099
|
4.995 score on a scale
Standard Deviation 2.9470
|
|
Patient Reported Outcome: Change From Baseline in Pain Severity/Pain Interference Domain From Brief Pain Inventory (BPI) Questionnaire
Pain Interence: CFB to Day 15 (n=38,42,47)
|
-0.674 score on a scale
Standard Deviation 2.2868
|
-0.099 score on a scale
Standard Deviation 2.0435
|
-0.816 score on a scale
Standard Deviation 2.3556
|
|
Patient Reported Outcome: Change From Baseline in Pain Severity/Pain Interference Domain From Brief Pain Inventory (BPI) Questionnaire
Pain Interence: CFB to Wk 14 (n=32,33,33)
|
-0.213 score on a scale
Standard Deviation 2.3988
|
-0.534 score on a scale
Standard Deviation 2.7769
|
-0.039 score on a scale
Standard Deviation 3.0412
|
|
Patient Reported Outcome: Change From Baseline in Pain Severity/Pain Interference Domain From Brief Pain Inventory (BPI) Questionnaire
Pain Interference: CFB to Wk 26 (n=27,32,32)
|
-0.583 score on a scale
Standard Deviation 2.2844
|
-0.728 score on a scale
Standard Deviation 2.4220
|
-0.821 score on a scale
Standard Deviation 3.1561
|
|
Patient Reported Outcome: Change From Baseline in Pain Severity/Pain Interference Domain From Brief Pain Inventory (BPI) Questionnaire
Pain Interference: CFB to Wk 38 (n=25,29,29)
|
-0.866 score on a scale
Standard Deviation 2.7720
|
-0.119 score on a scale
Standard Deviation 1.6473
|
-0.221 score on a scale
Standard Deviation 3.1076
|
|
Patient Reported Outcome: Change From Baseline in Pain Severity/Pain Interference Domain From Brief Pain Inventory (BPI) Questionnaire
Pain Interference: CFB to Wk 52 (n=18,23,22)
|
-1.014 score on a scale
Standard Deviation 2.0989
|
-0.174 score on a scale
Standard Deviation 2.2510
|
-0.819 score on a scale
Standard Deviation 2.8490
|
|
Patient Reported Outcome: Change From Baseline in Pain Severity/Pain Interference Domain From Brief Pain Inventory (BPI) Questionnaire
Pain Interference: CFB to Wk 58 f/up (n=27,33,30)
|
-0.476 score on a scale
Standard Deviation 2.3473
|
-0.386 score on a scale
Standard Deviation 2.2249
|
-0.802 score on a scale
Standard Deviation 2.5785
|
Adverse Events
High-dose SelG1 (5.0 mg/kg SelG1)
Serious events: 17 serious events
Other events: 46 other events
Deaths: 2 deaths
Low-dose SelG1 (2.5 mg/kg SelG10
Serious events: 21 serious events
Other events: 47 other events
Deaths: 1 deaths
Placebo
Serious events: 17 serious events
Other events: 42 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
High-dose SelG1 (5.0 mg/kg SelG1)
n=66 participants at risk
IV Infusion, once every 4 weeks through Week 50
|
Low-dose SelG1 (2.5 mg/kg SelG10
n=64 participants at risk
IV Infusion, once every 4 weeks through Week 50
|
Placebo
n=62 participants at risk
IV Infusion, once every 4 weeks through Week 50
|
|---|---|---|---|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Cardiac disorders
RIGHT VENTRICULAR FAILURE
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Congenital, familial and genetic disorders
SICKLE CELL ANAEMIA WITH CRISIS
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
3.2%
2/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Endocrine disorders
HYPERPARATHYROIDISM PRIMARY
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Cardiac disorders
BRADYCARDIA
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
General disorders
PYREXIA
|
3.0%
2/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
General disorders
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
ARTHRITIS INFECTIVE
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
ATYPICAL PNEUMONIA
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
CELLULITIS
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
ENDOCARDITIS
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
4.7%
3/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
OSTEOMYELITIS
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
PNEUMONIA
|
4.5%
3/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
3.1%
2/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
4.8%
3/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
SEPSIS
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
TOOTH INFECTION
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
4.8%
3/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
VIRAL INFECTION
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Injury, poisoning and procedural complications
ACUTE HAEMOLYTIC TRANSFUSION REACTION
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Nervous system disorders
COMA
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Nervous system disorders
SYNCOPE
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Pregnancy, puerperium and perinatal conditions
PRE-ECLAMPSIA
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Renal and urinary disorders
RENAL PAPILLARY NECROSIS
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Renal and urinary disorders
URINARY RETENTION
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE CHEST SYNDROME
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Respiratory, thoracic and mediastinal disorders
STATUS ASTHMATICUS
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Surgical and medical procedures
ABORTION INDUCED
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Surgical and medical procedures
CENTRAL VENOUS CATHETERISATION
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Surgical and medical procedures
HYSTERECTOMY
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Vascular disorders
ANGIOPATHY
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Vascular disorders
HYPOTENSION
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Vascular disorders
VENOUS THROMBOSIS LIMB
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
Other adverse events
| Measure |
High-dose SelG1 (5.0 mg/kg SelG1)
n=66 participants at risk
IV Infusion, once every 4 weeks through Week 50
|
Low-dose SelG1 (2.5 mg/kg SelG10
n=64 participants at risk
IV Infusion, once every 4 weeks through Week 50
|
Placebo
n=62 participants at risk
IV Infusion, once every 4 weeks through Week 50
|
|---|---|---|---|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
3.0%
2/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
3.1%
2/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
6.5%
4/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
6.1%
4/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
4.7%
3/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
3.0%
2/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Gastrointestinal disorders
CONSTIPATION
|
6.1%
4/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
3.1%
2/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
4.8%
3/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Gastrointestinal disorders
DIARRHOEA
|
10.6%
7/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
7.8%
5/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Gastrointestinal disorders
NAUSEA
|
18.2%
12/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
17.2%
11/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
11.3%
7/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Gastrointestinal disorders
VOMITING
|
7.6%
5/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
10.9%
7/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
4.8%
3/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
General disorders
CHEST PAIN
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
10.9%
7/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
General disorders
FATIGUE
|
7.6%
5/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
3.1%
2/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
3.2%
2/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
4.5%
3/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
3.1%
2/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
6.5%
4/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
General disorders
PAIN
|
3.0%
2/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
4.7%
3/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
9.7%
6/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
General disorders
PYREXIA
|
7.6%
5/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
9.4%
6/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
4.8%
3/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
NASOPHARYNGITIS
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
4.7%
3/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
6.5%
4/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
10.6%
7/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
10.9%
7/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
9.7%
6/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
12.1%
8/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
9.4%
6/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
9.7%
6/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
7.8%
5/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
3.2%
2/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Investigations
PROTHROMBIN TIME PROLONGED
|
4.5%
3/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
3.1%
2/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
8.1%
5/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
3.1%
2/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
8.1%
5/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
18.2%
12/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
14.1%
9/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
8.1%
5/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
15.2%
10/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
18.8%
12/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
11.3%
7/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
7.6%
5/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
12.1%
8/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
9.7%
6/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
7.6%
5/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
3.1%
2/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
0.00%
0/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
4.7%
3/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
6.5%
4/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
16.7%
11/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
12.5%
8/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
16.1%
10/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Nervous system disorders
DIZZINESS
|
4.5%
3/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
8.1%
5/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Nervous system disorders
HEADACHE
|
16.7%
11/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
21.9%
14/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
16.1%
10/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
6.1%
4/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
11.3%
7/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.5%
1/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
6.2%
4/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
3.2%
2/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
6.1%
4/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
4.7%
3/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
1.6%
1/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
7.6%
5/66 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
10.9%
7/64 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
4.8%
3/62 • Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment, up to a maximum duration of 58 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment. Of the 198 patients randomized, 192 received at least one dose of study treatment and were included in the Safety set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER